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Eligibility Type 2 Diabetic Nephropathy NCT01488877

- 1/28/19 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy; ODM derived from: https://clinicaltrials.gov/show/NCT01488877

Eligibility Diabetic Nephropathy NCT00556465

- 3/13/18 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Efficacy of N-Acetylcysteine in Treatment of Overt Diabetic Nephropathy; ODM derived from: https://clinicaltrials.gov/show/NCT00556465

Eligibility Diabetic Nephropathy NCT00141453

- 9/7/16 - 1 form, 2 itemgroups, 18 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00141453

dbGaP phs000302 Genetic Study on Nephropathy in Type-2 Diabetes - Eligibility

- 10/12/22 - 4 forms, 1 itemgroup, 11 items, 1 language
Itemgroup: IG.elig
Principal Investigator: Andrzej Krolewski, MD, PhD, Joslin Diabetes Center, Boston, MA, USA MeSH: Diabetic Nephropathies https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000302 A collection of patients with type-2 diabetes was collected at the Joslin Diabetes Center. Patients were categorized to a group of cases with diabetic nephropathy, and a group of controls with normoalbuminuria. From these groups, 173 cases and 177 controls were randomly selected for a genome-wide association study.

pht002176.v1.p1

1 itemgroup 2 items

pht002177.v1.p1

1 itemgroup 2 items

pht002178.v1.p1

1 itemgroup 11 items

dbGaP phs000333 Family Investigation of Nephropathy and Diabetes (FIND) Study - Eligibility

- 10/12/22 - 6 forms, 1 itemgroup, 17 items, 1 language
Itemgroup: IG.elig
Principal Investigator: Sudha K. Iyengar, PhD, Case Western Reserve University, Cleveland, OH, USA MeSH: Diabetes Mellitus,Kidney Diseases,Diabetic Nephropathies https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000333 The Family Investigation of Nephropathy and Diabetes (FIND) is a multicenter study designed to identify genetic determinants of diabetic kidney disease. Study subjects were recruited from eleven centers and in many ethnic groups throughout the United States. A genome-wide association study (GWAS) was conducted with the Affymetrix 6.0 chip. Subjects (index cases) with diabetes and kidney disease were initially recruited, and their parents and siblings were invited to participate. Genetic material from these participants was used to genotype markers throughout the genome. For association-based testing, a case-control design was implemented with study subjects selected primarily from the index cases of the families. Unrelated controls were selected from families where a case was not already selected. Several study sites also contributed non-FIND subjects, both cases and controls (consent forms for the release of FIND and non-FIND subjects/samples are included in this dbGaP release). Cases were selected if they met study criteria for diabetic nephropathy or met inclusion criteria based on elevated serum creatinine levels and abnormal urine protein excretion. Similarly, controls were long-term diabetics with otherwise normal kidney function. See inclusion/exclusion criteria section for a detailed description for the FIND study as a whole and this GWAS. The goal of the FIND study is to identify genes that influence susceptibility to diabetic kidney disease, leading to a better understanding of how kidney disease develops. In the long run, this may lead to improved treatment and prevention of diabetic kidney disease.

pht002311.v1.p1

1 itemgroup 3 items

pht002312.v1.p1

1 itemgroup 5 items

pht002313.v1.p1

1 itemgroup 2 items

pht002314.v1.p1

1 itemgroup 42 items

pht002315.v1.p1

1 itemgroup 4 items

dbGaP phs000018 Search for Susceptibility Genes for Diabetic Nephropathy in Type 1 Diabetes (GoKinD study participants), GAIN - Eligibility

- 1/22/25 - 6 forms, 1 itemgroup, 32 items, 1 language
Itemgroup: IG.elig
Principal Investigator: J.H. Warram, Joslin Diabetes Center, Boston, MA, USA MeSH: https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000018 Genetics of Kidneys in Diabetes (GoKinD) study is an initiative aimed at identifying susceptibility genes for diabetic nephropathy in type 1 diabetes. A large number of individuals with type 1 diabetes were screened to identify two subsets, one with clear-cut kidney disease and another with normal renal status despite long-term diabetes. Those who met additional entry criteria and consented to participate were enrolled. When possible, both parents were also enrolled to form family trios. Altogether, GoKinD includes 3043 participants comprising 931 cases, 944 singletons, 268 pairs of parents of cases, and 316 pairs of parents of control. Accessible as a GAIN database are 905 of the cases, 890 of the controls, 10 pairs of parents of cases and 10 pairs of parents of controls. The other parents and the remaining cases and controls are available by a separate application process through NIDDK (dbGaP phs000088 *Search for Susceptibility Genes for Diabetic Nephropathy in Type 1 Diabetes (GoKinD study participants and parents), NIDDK*). Interested investigators may request the DNA collection and corresponding clinical data for GoKinD participants using the instructions and application form available at Juvenile Diabetes Research Foundation. *Consent groups and participant set* - Diabetic complications only (DCO): 1825 (904 cases, 881 controls, 40 others)

pht004354.v1.p1

1 itemgroup 2 items

pht004355.v1.p1

1 itemgroup 6 items

pht004356.v1.p1

1 itemgroup 4 items

pht000062.v1.p1

1 itemgroup 54 items

pht004357.v1.p1

1 itemgroup 2 items

dbGaP phs000088 Search for Susceptibility Genes for Diabetic Nephropathy in Type 1 Diabetes (GoKinD study participants and parents), NIDDK - pht000713.v1.p1

- 10/12/22 - 5 forms, 1 itemgroup, 3 items, 1 language
Itemgroup: pht000713
Principal Investigator: J.H. Warram, Joslin Diabetes Center, Boston, MA, USA MeSH: Diabetic Nephropathies https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000088 Genetics of Kidneys in Diabetes (GoKinD) study is an initiative aimed at identifying susceptibility genes for diabetic nephropathy in type 1 diabetes. A large number of individuals with type 1 diabetes were screened to identify two subsets, one with clear-cut kidney disease and another with normal renal status despite long-term diabetes. Those who met additional entry criteria and consented to participate were enrolled. When possible, both parents were also enrolled to form family trios. Altogether, GoKinD includes 3043 participants comprising 931 cases, 944 singletons, 268 pairs of parents of cases, and 316 pairs of parents of control. Accessible as a GAIN database are 905 of the cases, 890 of the controls, 10 pairs of parents of cases and 10 pairs of parents of controls (dbGaP phs000018 *Search for Susceptibility Genes for Diabetic Nephropathy in Type 1 Diabetes (GoKinD study participants), GAIN*). The other parents and the remaining cases and controls are available by a separate application process through NIDDK. Interested investigators may request the DNA collection and corresponding clinical data for GoKinD participants using the instructions and application form available at http://www.niddkrepository.org or by contacting the Juvenile Diabetes Research Foundation.

Eligibility

1 itemgroup 32 items

pht000072.v1.p1

1 itemgroup 54 items

pht000712.v1.p1

1 itemgroup 5 items

pht000711.v1.p1

1 itemgroup 2 items

dbGaP phs000389 GENIE UK-ROI Diabetic Nephropathy GWAS - Eligibility

- 10/12/22 - 4 forms, 1 itemgroup, 3 items, 1 language
Itemgroup: IG.elig
Principal Investigator: Joel Hirschhorn, Broad Institute and Children's Hospital Boston, Boston, MA, USA MeSH: Diabetic Nephropathy,Kidney Failure, Chronic,Albuminuria,Diabetes Mellitus, Type 1,Diabetes Complications https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000389 Diabetic kidney disease, or diabetic nephropathy (DN), is one of the leading causes of end-stage renal disease in the United States and worldwide. DN is a common complication of long-standing type 1 and type 2 diabetes. The clinical course is characterized by development of proteinuria and gradual loss of kidney function. Although existing treatments that decrease proteinuria have been shown to moderately abate progression of diabetic kidney disease, many affected patients, who do not die from cardiovascular disease, go on to develop terminal renal failure, necessitating costly renal replacement therapies, such as dialysis and renal transplantation. Type 1 diabetes (T1D) can have its onset in childhood and affected individuals often develop end-stage renal disease in early adulthood, leading to further loss of quality of life. The genetic basis of the disease is not well understood. The GENIE (*GE*netics of *N*ephropathy an *I*nternational *E*ffort) consortium was initiated to perform the most comprehensive and well powered DN susceptibility genome wide association study (GWAS) analysis to date, using the largest collection of type 1 diabetics with and without kidney disease across four study cohorts. The UK-ROI samples were genotyped as part of this project. *UK-ROI Sample Description* The UK-ROI collection consists of samples derived from the Republic of Ireland (Dr. Catherine Godson, PI, at University College, Dublin, Ireland) and the United Kingdom (Warren 3 and Genetics of Kidneys in Diabetes UK, *UK GoKinD*, Dr. Alexander P. Maxwell, PI, at Queen's University of Belfast, UK). All study subjects met the inclusion criteria: white individuals with T1D, diagnosed before 31 years of age, whose parents and grandparents were born in the British Isles.

pht002377.v1.p1

1 itemgroup 5 items

pht002378.v1.p1

1 itemgroup 4 items

pht002379.v1.p1

1 itemgroup 13 items

Eligibility Diabetic Nephropathies NCT01968668

- 11/28/19 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (ARTS-DN Japan); ODM derived from: https://clinicaltrials.gov/show/NCT01968668

Eligibility Diabetic Nephropathy NCT01447147

- 11/27/19 - 1 form, 1 itemgroup, 14 items, 1 language
Itemgroup: Criteria
A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy; ODM derived from: https://clinicaltrials.gov/show/NCT01447147

Eligibility Diabetic Nephropathy NCT02237352

- 11/21/19 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Mechanisms of Diabetic Nephropathy in Ecuador; ODM derived from: https://clinicaltrials.gov/show/NCT02237352

Eligibility Diabetic Nephropathy NCT01843387

- 11/21/19 - 1 form, 2 itemgroups, 16 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy; ODM derived from: https://clinicaltrials.gov/show/NCT01843387

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