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OpenTrials
Completed

NCT Number: NCT05407740

"Association of Proteinuria and Progression of Kidney Dysfunction in Sickle Cell Disease"Disease

To describe change in ACR and eGFR during study follow-up, and assesss the association of baseline and change in ACR and eGFR, with progression of kidney failure and/or all-cause mortality.

Completed

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Key information

Conditions

Change in Albumin to Creatinine Ratio and Glomerular Filtration Rate Progression of Kidney Failure and or All-cause Mortality

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Henri Mondor Hospital

Créteil, 94000, France

About this study

This is a retrospective, non-interventional, secondary use of the data coming from the single-center secondary GEN-MOD study cohort at the Henri Mondor Hospital (Creteil, France). The GEN-MOD cohort includes 355 SCD patients.

The GEN-MOD data are accessible through the center's clinical and laboratory database and will be extracted and analyzed for the purpose of this study.

The enrolment in the GEN-MOD cohort lasted from 01 December 2002 until 01 March 2014. Follow-up occurred every six months and ranged from five to seventeen years and ended on 31 December 2019. The index date (baseline) for this study is the time of inclusion of patients in GEN-MOD cohort study

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged ≥ 18 years old.
  • Confirmed diagnosis of SCD by Hb electrophoresis or high performance liquid chromatography. SCD genotypes HbSS, HbSβ0-thal.
  • Availability of ACR and eGFR baseline records.

Exclusion criteria

  • Patients enrolled in a chronic transfusion program.
  • Patients receiving hydroxyurea treatment at the time of study enrollment.

Treatment and study plan

No intervention study

Other

no intervention study

Primary outcomes

  1. Change in albumin to creatinine(ACR) and glomerular filtration rate(eGFR)

    Time frame: 10 years

    To describe change in ACR and eGFR during study follow-up, and assesss the association of baseline and change in ACR and eGFR, with progression of kidney failure and/or all-cause mortality

Secondary outcomes

  1. Progression of kidney dysfunction

    Time frame: 10 years

    •To assess the association of baseline and change in ACR, and CKD progression category

  2. Change in ACR

    Time frame: 10 years

    To assess potential risk factors (at baseline) for ACR elevation during study follow-up

Other outcomes

  1. GFR decline

    Time frame: 10 years

    To assess potential risk factors (at baseline) for eGFR decline during study follow-up.

Sponsors and collaborators

Lead sponsor

Soutien aux Actions contre les Maladies du Globule Rouge

Other

Collaborators

  • Novartis

Registry information

Official study title

"ASsociation of Proteinuria and Progression of KidneY DysfunctioN in Sickle Cell Disease"

Acronym: CSEG101A0FR01

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 7, 2022
Registry last updated
May 16, 2024

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.