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NCT Number: NCT03723512

Non-contrast Enhanced MRI in Patients With C3 Glomerulopathy (C3G) or Immune-complex Membranoproliferative Glomerulonephritis (IC-MPGN) Enrolled in the ACH471-205 Study

Functional and quantitative renal magnetic resonance imaging (MRI) has seen a number of recent advances, and techniques are now available that can generate quantitative imaging biomarkers with the potential to improve the management of kidney disease.

However, there are knowledge gaps that must be addressed before renal MRI methods could be more widely adopted in clinical research and ultimately be transferred to clinical practice, including the biological basis of different MRI biomarkers, and how the application of these biomarkers will improve patient care.

Among renal MRI techniques, renal diffusion weighted MRI (DWI) has been increasingly used in the last decade, showing high potential as a surrogate and monitoring biomarker for interstitial fibrosis in chronic kidney disease (CKD), as well as a surrogate biomarker for the inflammation in acute kidney diseases that may impact patient selection for renal biopsy in acute graft rejection.

Within the ready-to-start ACH471-205 clinical trial, an Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) treated with ACH-0144471, aimed at evaluating the efficacy of 12 months of oral ACH-0144471 in patients with C3G or IC-MPGN, patients will undergo baseline and 12-month follow-up renal biopsies, and renal function will be assessed over time by estimated or measured (when available) glomerular filtration rate (GFR). Adding multi-parametric NCE-MRI to the examinations under the ACH471-205 study protocol will give the opportunity to elucidate, in a well-defined cohort of patients, the potential of NCE-MRI as biomarker of renal microstructure and functional change.

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Key information

Conditions

C3 Glomerulonephritis C3 Glomerulopathy Dense Deposit Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, Membranoproliferative IC-MPGN Immune Complex Membranoproliferative Glomerulonephritis Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

17 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò

Ranica, BG, 24020, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of C3G or IC-MPGN;
  • Patients enrolled in the ACH471-205 study at the Bergamo center;
  • No contraindications to perform MRI.

Exclusion criteria

  • Ferro-magnetic prosthesis, aneurysm clips, severe claustrophobia or other contraindications or exclusions interfering with the MRI assessment.

Treatment and study plan

Non contrast-enhanced magnetic resonance imaging

Device

Non contrast-enhanced magnetic resonance imaging

Primary outcomes

  1. Median diffusivity (D) in the kidney, renal cortex and medulla.

    Time frame: At baseline (prior to baseline biopsy).

  2. Median diffusivity (D) in the kidney, renal cortex and medulla.

    Time frame: At 12 months (prior to follow-up biopsy).

Secondary outcomes

  1. Renal artery blood flow and renal plasma flow.

    Time frame: At baseline (prior to baseline biopsy).

  2. Renal artery blood flow and renal plasma flow.

    Time frame: At 12 months (prior to follow-up biopsy).

  3. Change in median diffusivity in the kidney, renal cortex and medulla after 12-month treatment with ACH-0144471.

    Time frame: At 12 months follow-up.

  4. Change in renal artery blood flow and renal plasma flow after 12-month treatment with ACH-0144471.

    Time frame: At 12 months follow-up.

Sponsors and collaborators

Lead sponsor

Mario Negri Institute for Pharmacological Research

Other

Collaborators

  • Alexion Pharmaceuticals, Inc.

Registry information

Official study title

Sub-project of the Clinical Protocol ACH471-205 "An Open-Label Phase 2 Proof-of-Concept Study in Patients With C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated With ACH-0144471"

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2018
Registry last updated
Nov 26, 2021

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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