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

NCT ID: NCT05407740

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

355 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-12-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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no intervention study

no intervention study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Soutien aux Actions contre les Maladies du Globule Rouge

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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PABLO BARTOLUCCI, PROFESSOR

Role: PRINCIPAL_INVESTIGATOR

Soutien aux Actions contre les Maladies du Globule Rouge

Locations

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Henri Mondor Hospital

Créteil, , France

Site Status

Countries

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France

Other Identifiers

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CSEG101A0FR01

Identifier Type: -

Identifier Source: org_study_id

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