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NCT Number: NCT05229263

Multiparametric MRI in Healthy Volunteers and CKD Patients

Chronic kidney disease (CKD) is a global health concern because more than 10% of the world's population have it, its prevalence is increasing, and CKD is an important contributor to morbidity and mortality for this population.

The majority of the people with CKD aren't aware and there are not available tools for early CKD detection and for an accurate prediction on these patients. Many CKD patients exhibit progressive renal dysfunction, demonstrating a failure of current, non-specific therapeutic strategies. Better methods are urgently needed for i) early diagnosis of CKD, and prediction of its progression for improved stratification of patients and better targeting of current treatments; and ii) to directly assess structural and functional responses of the kidney to new therapies and identify those patients who respond.

Over the past decade, renal Magnetic Resonance Imaging (MRI) has emerged as a promising technique for improved understanding and characterisation of renal pathophysiology. Compared to histopathology, MRI is non-invasive and avoids sampling bias by characterising the entire kidney with high spatial resolution.

In spite of a number of single centre studies showing renal MRI feasibility and potential to address a number of key clinical questions, current methodological differences across studies hinder reliable comparisons of the results, which can only be regarded as preliminary. Standardization of acquisition and processing protocols across centres is therefore needed, and this will also lead to the possibility to provide preliminary data of the multiparametric renal MRI clinical validity and utility.

The purpose of this study is to standardize, assess the feasibility and provide preliminary evidence of clinical validity and utility of the multiparametric renal MRI.

To reach this goal two groups of subjects are involved:

* Group 1 (healthy volunteers). In this group the repeatibility and reproducibility of multiparametric renal MRI will be assessed. * Group 2 (CKD patients). In this group the feasibility, the acceptability, the reproducibility and the preliminary clinical validity of multiparametric renal MRI will be assessed.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Healthy Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Department of Renal Medicine, Århus N, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

GROUP 1:

  • Provision of written informed consent prior to any study specific procedures
  • Male and female subjects aged more than18 years
  • Normotensive (office Systolic Blood Pressure values < 140 mmHg and Diastolic Blood Pressure values ≤ 90 mmHg)
  • Normal renal condition for age (established by estimating Glomerular Filtration Rate using CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration, Creatinine Equation)
  • Negative result upon urine dipstick testing for haematuria or proteinuria.
  • Normal Urine Albumin-to-Creatinine Ratio (UACR) (<30 mg/g)

GROUP 2:

  • Provision of written informed consent prior to any study specific procedures
  • Male and female patients aged more than18 years
  • CKD stage 2 or 3, with albuminuria up to 2000 mg

Exclusion criteria

GROUP 1 and 2

  • Previous enrollment in the present study
  • Contraindications to MRI including due to:
  • Claustrophobia
  • Pregnancy
  • Cardiac pacemakers or other MRI-incompatible prostheses

Only GROUP 2:

  • Urine Albumin-to-Creatinine Ratio higher than 2000 mg/g or 24h urine total albumin >2 g
  • Polycystic kidney disease, renovascular disease, active/current nephrotic syndrome, reflux nephropathy and known congenital renal diseases or solitary kidney.
  • Active malignancy or acute or chronic inflammatory disease, HIV
  • Acute kidney injury, as defined by the the KDIGO guidelines, during the last three months.
  • Need of a new immunosuppressive therapy for treating renal disease relapse in the preceding three months.
  • Dialysis or kidney transplantation
  • CKD stages 4 or 5
  • New medication in the preceding two weeks (diuretic, hypertensive, SGLT2 treatment)

Treatment and study plan

Non- contrast Enhanced Multiparametric Renal Magnetic Resonance

Diagnostic Test

MRI is performed in a single multiparametric scan session with no need for contrast agents, and to depict changes in tissue microstructure associated with inflammation and fibrosis plus alterations in oxygenation.

Primary outcomes

  1. GROUP 1: within subject total kidney volume coefficient of variation in few hour time

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess total kidney volume repeatability in the whole group of healthy volunteers

  2. GROUP 1: within subject total kidney volume coefficient of variation after 1-2 weeks

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess total kidney volume reproducibility in the whole group of healthy volunteers

  3. GROUP 1: within subject renal artery blood flow coefficient of variation in few hour time

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess renal artery blood flow repeatability in the whole group of healthy volunteers

  4. GROUP 1: within subject renal artery blood flow coefficient of variation after 1-2 weeks

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess renal artery blood flow reproducibility in the whole group of healthy volunteers

  5. GROUP 1: within subject cortical perfusion coefficient of variation in few hour time

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess cortical perfusion repeatability in the whole group of healthy volunteers

  6. GROUP 1: within subject cortical perfusion coefficient of variation after 1-2 weeks

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical perfusion reproducibility in the whole group of healthy volunteers

  7. GROUP 1: within subject cortical and medullary T1 coefficient of variation in few hour time

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess cortical and medullary T1 repeatability in the whole group of healthy volunteers

  8. GROUP 1: within subject cortical and medullary T1 coefficient of variation after 1-2 weeks

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical and medullary T1 reproducibility in the whole group of healthy volunteers

  9. GROUP 1: within subject cortical and medullary T2 coefficient of variation in few hour time

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess cortical and medullary T2 repeatability in the whole group of healthy volunteers

  10. GROUP 1: within subject cortical and medullary T2 coefficient of variation after 1-2 weeks

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical and medullary T2 reproducibility in the whole group of healthy volunteers

  11. GROUP 1: within subject cortical and medullary R2* coefficient of variation in few hour time

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess cortical and medullary R2* repeatability in the whole group of healthy volunteers

  12. GROUP 1: within subject cortical and medullary R2* coefficient of variation after 1-2 weeks

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical and medullary R2* reproducibility in the whole group of healthy volunteers

  13. GROUP 1: within subject cortical and medullary ADC coefficient of variation in few hour time

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess cortical and medullary ADC repeatability in the whole group of healthy volunteers

  14. GROUP 1: within subject cortical and medullary ADC coefficient of variation after 1-2 weeks

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical and medullary ADC reproducibility in the whole group of healthy volunteers

  15. GROUP 2 - Percentage of complete renal MRI data collection and analysis

    Time frame: At day 0

    Percentage of complete renal MRI data acquired and generated by MRI data processing in the whole group of CKD patients, to assess feasibility of multiparametric renal MRI in CKD patients

Secondary outcomes

  1. GROUP 1 - within subject renal total kidney volume coefficient of variation in few hour time by gender

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in male and female healthy volunteers to assess differences in total kidney volume repeatability between genders

  2. GROUP 1 - within subject renal artery blood flow coefficient of variation in few hour time by gender

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in male and female healthy volunteers to assess differences in renal artery blood flow repeatability between genders

  3. GROUP 1 - within subject cortical perfusion coefficient of variation in few hour time by gender

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in male and female healthy volunteers to assess differences in cortical perfusion repeatability between genders

  4. GROUP 1 - within subject cortical and medullary T1 coefficient of variation in few hour time by gender

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in male and female healthy volunteers to assess differences in cortical and medullary T1 repeatability between genders

  5. GROUP 1 - within subject cortical and medullary T2 coefficient of variation in few hour time by gender

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in male and female healthy volunteers to assess differences in cortical and medullary T2 repeatability between genders

  6. GROUP 1 - within subject cortical and medullary R2* coefficient of variation in few hour time by gender

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in male and female healthy volunteers to assess differences in cortical and medullary R2* repeatability between genders

  7. GROUP 1 - within subject cortical and medullary ADC coefficient of variation in few hour time by gender

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in male and female healthy volunteers to assess differences in cortical and medullary ADC repeatability between genders

  8. GROUP 1 - within subject total kidney volume coefficient of variation in few hour time by age

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in healthy volunteers of different age to assess differences in total kidney volume repeatability between age classes

  9. GROUP 1 - within subject renal artery blood flow coefficient of variation in few hour time by age

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in healthy volunteers of different age to assess difference in renal artery blood flow repeatability between age classes

  10. GROUP 1 - within subject cortical perfusion coefficient of variation in few hour time by age

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in healthy volunteers of different age to assess differences in cortical perfusion repeatability between age classes

  11. GROUP 1 - within subject cortical and medullary T1 coefficient of variation in few hour time by age

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in healthy volunteers of different age to assess differences in cortical and medullary T1 repeatability between age classes

  12. GROUP 1 - within subject cortical and medullary T2 coefficient of variation in few hour time by age

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in healthy volunteers of different age to assess differences in cortical and medullary T2 repeatability between age classes

  13. GROUP 1 - within subject cortical and medullary R2* coefficient of variation in few hour time by age

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in healthy volunteers of different age to assess differences in cortical and medullary R2* repeatability between age classes

  14. GROUP 1 - within subject cortical and medullary ADC coefficient of variation in few hour time by age

    Time frame: At day 0

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in healthy volunteers of different age to assess differences in cortical and medullary ADC repeatability between age classes

  15. GROUP 1 - within subject total kidney volume coefficient of variation after 1-2 weeks by gender

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks in male and female healthy volunteers to assess differences in total kidney volume reproducibility between genders

  16. GROUP 1 - within subject renal artery blood flow coefficient of variation after 1-2 weeks by gender

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks in male and female healthy volunteers to assess differences in renal artery blood flow reproducibility between genders

  17. GROUP 1 - within subject cortical perfusion coefficient of variation after 1-2 weeks by gender

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks in male and female healthy volunteers to assess differences in cortical perfusion reproducibility between genders

  18. GROUP 1 - within subject cortical and medullary T1 coefficient of variation after 1-2 weeks by gender

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks in male and female healthy volunteers to assess difference in cortical and medullary T1 reproducibility between genders

  19. GROUP 1 - within subject cortical and medullary T2 coefficient of variation after 1-2 weeks by gender

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks in male and female healthy volunteers to assess differences in cortical and medullary T2 reproducibility between genders

  20. GROUP 1 - within subject cortical and medullary R2* coefficient of variation after 1-2 weeks by gender

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks in male and female healthy volunteers to assess differences in cortical and medullary R2* reproducibility between genders

  21. GROUP 1 - within subject cortical and medullary ADC coefficient of variation after 1-2 weeks by gender

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks in male and female healthy volunteers to assess differences in cortical and medullary ADC reproducibility between genders

  22. GROUP 1 - within subject total kidney volume coefficient of variation after 1-2 weeks by age

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks in healthy volunteers of different age to assess differences in total kidney volume reproducibility between age classes

  23. GROUP 1 - within subject renal artery blood flow coefficient of variation after 1-2 weeks by age

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks in healthy volunteers of different age to assess differences in renal artery blood flow reproducibility between age classes

  24. GROUP 1 - within subject cortical perfusion coefficient of variation after 1-2 weeks by age

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI after 1-2 weeks in healthy volunteers of different age to assess differences in cortical perfusion reproducibility between age classes

  25. GROUP 1 - within subject cortical and medullary T1 coefficient of variation after 1-2 weeks by age

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI after 1-2 weeks in healthy volunteers of different age to assess differences in cortical and medullary T1 reproducibility between age classes

  26. GROUP 1 - within subject cortical and medullary T2 coefficient of variation after 1-2 weeks by age

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI after 1-2 weeks in healthy volunteers of different age to assess differences in cortical and medullary T2 reproducibility between age classes

  27. GROUP 1 - within subject cortical and medullary R2* coefficient of variation after 1-2 weeks by age

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI after 1-2 weeks in healthy volunteers of different age to assess differences in cortical and medullary R2* reproducibility between age classes

  28. GROUP 1 - within subject cortical and medullary ADC coefficient of variation after 1-2 weeks by age

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI after 1-2 weeks in healthy volunteers of different age to assess differences in cortical and medullary ADC reproducibility between age classes

  29. GROUP 1 - Multiparametric MRI acceptability in healthy volunteers.

    Time frame: At day 0

    Multiparametric MRI acceptability, in terms of comfort level and degree of satisfaction, assessed by a specific 9-item questionnaire ([9-45] range of values, with highest values denoting highest acceptability [Chen S, et al. J Appl Clin Med Phys. 2019; 20(7):184-192]) in healthy volunteers.

  30. GROUP 2 - Multiparametric MRI acceptability in CKD patients.

    Time frame: At day 0

    Multiparametric MRI acceptability, in terms of comfort level and degree of satisfaction, assessed by a specific 9-item questionnaire ([9-45] range of values, with highest values denoting highest acceptability [Chen S, et al. J Appl Clin Med Phys. 2019; 20(7):184-192]) in CKD patients.

  31. GROUP 2 - within subject total kidney volume coefficient of variation after 1-2 weeks

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess total kidney volume reproducibility in CKD patients

  32. GROUP 2 - within subject renal artery blood flow coefficient of variation after 1-2 weeks

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess renal artery blood flow reproducibility in CKD patients

  33. GROUP 2 - within subject cortical perfusion coefficient of variation after 1-2 weeks

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical perfusion reproducibility in CKD patients

  34. GROUP 2 - within subject cortical and medullary T1 coefficient of variation after 1-2 weeks

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical and medullary T1 reproducibility in CKD patients

  35. GROUP 2 - within subject cortical and medullary T2 coefficient of variation after 1-2 weeks

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical and medullary T2 reproducibility in CKD patients

  36. GROUP 2 - within subject cortical and medullary R2* coefficient of variation after 1-2 weeks

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MR repeated after 1-2 weeks to assess cortical and medullary R2* reproducibility in CKD patients

  37. GROUP 2 - within subject cortical and medullary ADC coefficient of variation after 1-2 weeks

    Time frame: At day 7-14

    Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical and medullary ADC reproducibility in CKD patients

  38. GROUP 2 - Correlation coefficient between MRI-based parameters and eGFR

    Time frame: At day 0

    Assessment of the correlation coefficient between MRI-based parameters and eGFR to provide preliminary evidence of the nature and degree of change in multiparametric MRI measures across different stages of CKD

Sponsors and collaborators

Lead sponsor

Mario Negri Institute for Pharmacological Research

Other

Collaborators

  • Aarhus University Hospital
  • Clinica Universidad de Navarra, Universidad de Navarra
  • Heidelberg University

Registry information

Official study title

Exploratory Multicentre Clinical Study to Assess Repeatibility, Reproducibility, Acceptability and Clinical Validity of Multiparametric Renal Magnetic Resonance Imaging

Acronym: RESPECT

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2022
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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