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

• ClinicalTrials.gov Identifier: NCT05407740
• Recruitment Status: Completed
• First Posted: June 7, 2022
• Last Update Posted: June 7, 2022
• Sponsor: Soutien aux Actions contre les Maladies du Globule Rouge
• Collaborator: Novartis
• Information provided by (Responsible Party): Soutien aux Actions contre les Maladies du Globule Rouge

Tracking Information

• First Submitted Date: April 4, 2022
• First Posted Date: June 7, 2022
• Last Update Posted Date: June 7, 2022
• Actual Study Start Date: March 1, 2021
• Actual Primary Completion Date: March 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 1, 2022)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: June 1, 2022)

• Progression of kidney dysfunction [ Time Frame: 10 years ]
  •To assess the association of baseline and change in ACR, and CKD progression category
• ACR elevation [ Time Frame: 10 years ]
  To assess potential risk factors (at baseline) for ACR elevation during study follow-up

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: June 1, 2022)

GFR decline [ Time Frame: 10 years ]

To assess potential risk factors (at baseline) for eGFR decline during study follow-up.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: "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"
• 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

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

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

Intervention

Other: no intervention study

no intervention study

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 1, 2022): 355
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 1, 2021
• Actual Primary Completion Date: March 1, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT05407740
• Other Study ID Numbers: CSEG101A0FR01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Soutien aux Actions contre les Maladies du Globule Rouge
• Original Responsible Party: Same as current
• Current Study Sponsor: Soutien aux Actions contre les Maladies du Globule Rouge
• Original Study Sponsor: Same as current
• Collaborators: Novartis

Investigators

• Principal Investigator: PABLO BARTOLUCCI, PROFESSOR; Soutien aux Actions contre les Maladies du Globule Rouge

• PRS Account: Soutien aux Actions contre les Maladies du Globule Rouge
• Verification Date: June 2022