"Association of Proteinuria and Progression of Kidney Dysfunction in Sickle Cell Disease"Disease (CSEG101A0FR01)

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

Study Overview

• Status: Completed
• Conditions: Change in Albumin to Creatinine Ratio and Glomerular Filtration Rate; Progression of Kidney Failure and or All-cause Mortality
• Intervention / Treatment: Other: no intervention study

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 Type: Observational
• Enrollment (Actual): 355

Contacts and Locations

Study Locations

• France
  • Creteil, France, 94000
    • Henri Mondor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in albumin to creatinine(ACR) and glomerular filtration rate(eGFR)	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	10 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
GFR decline	To assess potential risk factors (at baseline) for eGFR decline during study follow-up.	10 years

Collaborators and Investigators

• Sponsor: Soutien aux Actions contre les Maladies du Globule Rouge
• Collaborators: Novartis
• Investigators: Principal Investigator: PABLO BARTOLUCCI, PROFESSOR, Soutien aux Actions contre les Maladies du Globule Rouge

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Urological Manifestations; Disease Attributes; Hematologic Diseases; Genetic Diseases, Inborn; Urination Disorders; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Progression; Proteinuria; Renal Insufficiency; Anemia, Sickle Cell
• Other Study ID Numbers: CSEG101A0FR01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No