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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention study | Other | no intervention study |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| GFR decline | To assess potential risk factors (at baseline) for eGFR decline during study follow-up. | 10 years |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| PABLO BARTOLUCCI, PROFESSOR | Soutien aux Actions contre les Maladies du Globule Rouge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henri Mondor Hospital | Créteil | 94000 | France |
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| 10 years |