Change in Albumin to Creatinine Ratio and Glomerular Filtration RateCSEG101A0FR01NCT05407740
"Association of Proteinuria and Progression of Kidney Dysfunction in Sickle Cell Disease"Disease
An observational study of Change in Albumin to Creatinine Ratio and Glomerular Filtration Rate and Progression of Kidney Failure and or All-cause Mortality, run by Soutien aux Actions contre les Maladies du Globule Rouge at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Change in Albumin to Creatinine Ratio and Glomerular Filtration Rate, Progression of Kidney Failure and or All-cause Mortality
- How many people
- 355 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients enrolled in a chronic transfusion program.
- Patients receiving hydroxyurea treatment at the time of study enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "ASsociation of Proteinuria and Progression of KidneY DysfunctioN in Sickle Cell Disease"
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.
Read the 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
- Conditions
- Change in Albumin to Creatinine Ratio and Glomerular Filtration Rate, Progression of Kidney Failure and or All-cause Mortality
- Being tested
- no intervention study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention studyOther
no intervention study
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Secondary outcomes (2)
Progression of kidney dysfunction
•To assess the association of baseline and change in ACR, and CKD progression category
Measured: 10 years
Change in ACR
To assess potential risk factors (at baseline) for ACR elevation during study follow-up
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Mar 2021
- Primary completion1 Mar 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Change in Albumin to Creatinine Ratio and Glomerular Filtration RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soutien aux Actions contre les Maladies du Globule Rouge
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- PABLO BARTOLUCCI, PROFESSOR, Principal investigator, Soutien aux Actions contre les Maladies du Globule Rouge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407740
- Sponsor's protocol ID
- CSEG101A0FR01
- Acronym
- CSEG101A0FR01
- Status last verified
- May 2024
- First submitted
- 4 Apr 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "ASsociation of Proteinuria and Progression of KidneY DysfunctioN in Sickle Cell Disease"
- ClinicalTrials.gov ID
- NCT05407740
- Acronym / sponsor ID
- CSEG101A0FR01 / CSEG101A0FR01
- Conditions
- Change in Albumin to Creatinine Ratio and Glomerular Filtration Rate, Progression of Kidney Failure and or All-cause Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Soutien aux Actions contre les Maladies du Globule RougeUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients enrolled in a chronic transfusion program.
- Patients receiving hydroxyurea treatment at the time of study enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention studyno intervention study | Other | – |
Primary outcome
Change in 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
2 secondary outcomes
Progression of kidney dysfunction
Time frame: 10 years
Change in ACR
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PABLO BARTOLUCCI, PROFESSOR principal investigator
Soutien aux Actions contre les Maladies du Globule Rouge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Change in Albumin to Creatinine Ratio and Glomerular Filtration Rate and Progression of Kidney Failure and or All-cause Mortality, run by Soutien aux Actions contre les Maladies du Globule Rouge at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in albumin to creatinine(ACR) and glomerular filtration rate(eGFR) (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.