Linkage Consortium for End-Stage Renal Disease
|First Received Date ICMJE||March 9, 2006|
|Last Updated Date||January 12, 2010|
|Start Date ICMJE||October 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00301249 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Linkage Consortium for End-Stage Renal Disease|
|Official Title ICMJE||The Family Investigation of Nephropathy and Diabetes (FIND) Study|
The Family Investigation of Nephropathy and Diabetes (FIND)Study is a multi-center consortium. The charge of the consortium is to acquire sets of families with well-characterized diabetic nephropathy, establish a secure master FIND database, and perform a genome scan to identify chromosomal regions linked with diabetic nephropathy.
Diabetic Nephropathy (DN) is undoubtedly a multifactorial disease, and a large proportion of patients affected with either type 1 or type 2 diabetes develop diabetic nephropathy and progress to end stage renal disease (ESRD). When poor prognostic factors such as hypertension and chronic hyperglycemia are aggressively treated, the rate of progression of diabetic nephropathy can be slowed. However, no interventions have been shown to reliably halt the progression of diabetic nephropathy. Numerous studies have suggested that genetic predisposition to diabetic nephropathy exists, but genes for nephropathy have not yet been isolated. It is anticipated that a comprehensive analysis of a large number of uniformly phenotyped ESRD families will be necessary to isolate genes for ESRD. Such a database of families may not be available at any single institution. The FIND study has established a centralized Genetic Analysis and Data Coordinating Center (GADCC) that, together with eight participating investigation centers (PICs), three minority recruitment centers, and the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), will use the emerging high-throughput genetic technologies to enable identification of diabetic nephropathy susceptibility or protection genes. The charge of the consortium is to acquire sets of families with well-characterized diabetic nephropathy, establish a secure master FIND database, and perform a genome scan to identify chromosomal regions linked with diabetic nephropathy. The FIND study population includes participants from European American (EA), Native American (NA), African American (AA) and Mexican American (AA) populations.
Two analytic approaches are utilized in FIND. The Family Study approach involves the enrollment of probands, affected or discordant sibling and their affected family members. Analytic methods include affected sibling pair (ASP), discordant sibling pair (DSP) affected relative pair (ARP), and discordant relative pair (DRP) linkage analyses for the Family Study. The Mapping by Admixture and Linkage Disequilibrium (MALD) approach involves the enrollment of probands and a population based control for both the AA and MA studies. In addition, a spousal control (diad) and when available, a child 18 years or older, will be recruited (triad)for the AA MALD study only.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Knowler WC, Coresh J, Elston RC, Freedman BI, Iyengar SK, Kimmel PL, Olson JM, Plaetke R, Sedor JR, Seldin MF; Family Investigation of Nephropathy and Diabetes Research Group. The Family Investigation of Nephropathy and Diabetes (FIND): design and methods. J Diabetes Complications. 2005 Jan-Feb;19(1):1-9. Review.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||November 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
For the Family protocol, proband must meet diagnostic criteria for diabetes and have nephropathy that meets one of the following:
African-American patients with chronic renal failure are as MALD cases by meeting criteria for diabetic nephropathy, as described for Family probands, or having nephropathy (serum creatinine ≥ 2.0 mg/dl) not due to diabetes or known monogenic renal disease. Mexican-Americans recruited as MALD cases must meet criteria for diabetic nephropathy as defined for the Family probands. Phenotype criteria for probands entered into the Family or MALD protocols must be confirmed by medical record review.
Eligibility of family members and MALD control subjects is based on laboratory tests obtained at the time of screening. Entry of a proband with diabetic nephropathy into the Family protocol also requires participation of either two living parents or at least one full sibling with diabetes. To be enrolled as having nephropathy, the diabetic sib must meet one of the following criteria:
The criteria for MALD control subjects differ by ethnic group. For the African-American MALD protocol, two different control samples are recruited. First, an adult offspring with or without renal disease and the other parent of the offspring, who cannot have evidence of renal disease, are collected as controls for African-American probands with either diabetic or non-diabetic nephropathy. Together with the probands, this forms a sample of triads (offspring and other parent) or dyads (spouse only). A second group of African-American control subjects consists of unrelated individuals with diabetes duration ≥ 10 years and without nephropathy (as defined above for diabetic sibs). For Mexican Americans, a single unrelated control population is recruited with diabetes duration ≥ 10 years but without nephropathy (as defined above for diabetic sibs).
A. Did not sign the informed consent: refusal to participate. B. Diagnosis not confirmed. C. Appropriate siblings not available. D. Judged not likely or unable to follow study protocol. E. Ethnicity of parents or grandparent not suitable. F. Spouse not available.
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00301249|
|Other Study ID Numbers ICMJE||DK57292 (completed)|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Verification Date||January 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP