CSEG101A0FR01: "Association of Proteinuria and Progression of Kidney Dysfunction in Sickle Cell Disease"Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- Progression of kidney dysfunction [10 years]
•To assess the association of baseline and change in ACR, and CKD progression category
- ACR elevation [10 years]
To assess potential risk factors (at baseline) for ACR elevation during study follow-up
Other Outcome Measures
- GFR decline [10 years]
To assess potential risk factors (at baseline) for eGFR decline during study follow-up.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults aged ≥ 18 years old.
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Confirmed diagnosis of SCD by Hb electrophoresis or high performance liquid chromatography. SCD genotypes HbSS, HbSβ0-thal.
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Availability of ACR and eGFR baseline records.
Exclusion Criteria:
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Patients enrolled in a chronic transfusion program.
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Patients receiving hydroxyurea treatment at the time of study enrollment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Henri Mondor Hospital | Creteil | France | 94000 |
Sponsors and Collaborators
- Soutien aux Actions contre les Maladies du Globule Rouge
- Novartis
Investigators
- Principal Investigator: PABLO BARTOLUCCI, PROFESSOR, Soutien aux Actions contre les Maladies du Globule Rouge
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSEG101A0FR01