APOL1 Gene Variants in African American Kidney Transplant Recipients

NCT01442402 | Terminated

• 1 other identifier: 2011P000734
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Aim 1: Determine if there is an association between the APOL1 risk variants and allograft survival and function in African Americans Aim 2: Determine if there is an association between the presence of APOL1 risk variants in an African American kidney transplant recipient and the risk of recurrent disease Aim 3: Investigate mechanisms of APOL1 associated kidney disease by prospectively following African American kidney transplant recipients throughout their clinical course.

Conditions

Transplant;Failure,Kidney; Kidney Disease; Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

• Allograft survival

  year 1, 3, 5

Secondary Outcomes (1)

• Allograft function as measured by serum creatinine

  creatinine levels at year-1, year-3 and year-5

Study Arms (2)

2 APOL1 genotypes

African American transplant recipients with homozygous APOL1 gene variants

0 or 1 APOL1 genotypes

African American transplant recipients without homozygous APOL1 gene variants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

African American Renal Transplant Patients

You may qualify if:

• self-reported African American
• years or older
• kidney transplant within 12 years
• Aim 2:
• self-reported African American
• years or older
• kidney transplant within 12 years
• recurrent or de novo glomerular disease on allograft kidney biopsy
• self-reported African American
• years or older
• kidney transplant within 12 years
• end stage kidney disease due to glomerular nephritis, clinically diagnosed or by native kidney biopsy

You may not qualify if:

• clinical evidence of recurrent disease (presence of proteinuria, hematuria, Creatinine \>2)
• Aim 3:
• self-reported African American
• years or older
• scheduled living kidney transplant

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Aims 1 and 2: Subjects will collect a saliva specimen in an Oragene®•DNA sample collection kit for genotyping. We will also collected any discarded (no longer utilized for clinical purposes) tissue from biopsies. Aim 3: Prior to transplant, subjects will collect saliva in an Oragene®•DNA sample collection kit for genotyping and 10cc of blood will be drawn into a Na heparin collection tube for APOL1 protein analysis. When applicable, plasmapheresis effluent will be collected. We will also collected any discarded (no longer utilized for clinical purposes)tissue from biopsies.

MeSH Terms

Conditions

Kidney Diseases; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anil K Chandraker, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Renal Transplantation

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: September 28, 2011
• Study Start: April 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

US (1)