Clinical trial NCT05407740: "Association of Proteinuria and Progression of Kidney Dysfunction in Sickle Cell Disease"Disease
Official title: "ASsociation of Proteinuria and Progression of KidneY DysfunctioN in Sickle Cell Disease"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Change in Albumin to Creatinine Ratio and Glomerular Filtration Rate
Progression of Kidney Failure and or All-cause Mortality
Lead sponsor: Soutien aux Actions contre les Maladies du Globule Rouge
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2022-06-07
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in albumin to creatinine(ACR) and glomerular filtration rate(eGFR)
timeFrame: 10 years
Secondary outcomes:
measure: Progression of kidney dysfunction
timeFrame: 10 years
measure: Change in ACR
timeFrame: 10 years
Other outcomes:
measure: GFR decline
timeFrame: 10 years
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: Soutien aux Actions contre les Maladies du Globule Rouge
name: PABLO BARTOLUCCI, PROFESSOR
role: PRINCIPAL_INVESTIGATOR
References: