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"Association of Proteinuria and Progression of Kidney Dysfunction in Sickle Cell Disease"Disease (CSEG101A0FR01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05407740
Recruitment Status : Completed
First Posted : June 7, 2022
Last Update Posted : June 7, 2022
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Soutien aux Actions contre les Maladies du Globule Rouge

Study Description
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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
Change in Albumin to Creatinine Ratio and Glomerular Filtration Rate Progression of Kidney Failure and or All-cause Mortality Other: no intervention study

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
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Study Type : Observational
Actual Enrollment : 355 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: "ASsociation of Proteinuria and Progression of KidneY DysfunctioN in Sickle Cell Disease"
Actual Study Start Date : March 1, 2021
Actual Primary Completion Date : March 1, 2021
Actual Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: no intervention study
    no intervention study

Outcome Measures
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Primary Outcome Measures :
  1. albumin to creatinine(ACR) and glomerular filtration rate(eGFR) [ Time Frame: 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 :
  1. Progression of kidney dysfunction [ Time Frame: 10 years ]
    •To assess the association of baseline and change in ACR, and CKD progression category

  2. ACR elevation [ Time Frame: 10 years ]
    To assess potential risk factors (at baseline) for ACR elevation during study follow-up


Other Outcome Measures:
  1. GFR decline [ Time Frame: 10 years ]
    To assess potential risk factors (at baseline) for eGFR decline during study follow-up.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05407740


Locations
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France
Henri Mondor Hospital
Creteil, France, 94000
Sponsors and Collaborators
Soutien aux Actions contre les Maladies du Globule Rouge
Novartis
Investigators
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Principal Investigator: PABLO BARTOLUCCI, PROFESSOR Soutien aux Actions contre les Maladies du Globule Rouge
More Information
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Responsible Party: Soutien aux Actions contre les Maladies du Globule Rouge
ClinicalTrials.gov Identifier: NCT05407740    
Other Study ID Numbers: CSEG101A0FR01
First Posted: June 7, 2022    Key Record Dates
Last Update Posted: June 7, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Proteinuria
Anemia, Sickle Cell
Disease Progression
Disease Attributes
Pathologic Processes
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
 Hemoglobinopathies
Genetic Diseases, Inborn
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Urination Disorders
Urological Manifestations