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

Completed

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

• Registration Number: NCT05407740
• Lead Sponsor: Soutien aux Actions contre les Maladies du Globule Rouge

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-12-01
• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in albumin to creatinine(ACR) and glomerular filtration rate(eGFR)	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 Outcome Measures

Name	Time	Method
Progression of kidney dysfunction	10 years	•To assess the association of baseline and change in ACR, and CKD progression category
Change in ACR	10 years	To assess potential risk factors (at baseline) for ACR elevation during study follow-up

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Creteil, France