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

NCT05407740 | Completed DMC

• 1 other identifier: CSEG101A0FR01
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression of kidney dysfunction

  10 years

• Change in ACR

  10 years

Other Outcomes (1)

• GFR decline

  10 years

Interventions

no intervention study OTHER

no intervention study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Soutien aux Actions contre les Maladies du Globule Rouge: lead
• Novartis: collaborator

Study Sites (1)

Henri Mondor Hospital

Créteil, 94000, France

Location

Study Officials

• PABLO BARTOLUCCI, PROFESSOR

  Soutien aux Actions contre les Maladies du Globule Rouge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: June 7, 2022
• Study Start: March 1, 2021
• Primary Completion: March 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

FR (1)