Change in Albumin to Creatinine Ratio and Glomerular Filtration Rate, Progression of Kidney Failure and or All-cause Mortality
Conditions
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
Interventions
no intervention study
Sponsors
Novartis
Soutien aux Actions contre les Maladies du Globule Rouge
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| GFR decline | 10 years | To assess potential risk factors (at baseline) for eGFR decline during study follow-up. |
Countries
France
Outcome results
None listed