Genetic Testing to Understand and Address Renal Disease Disparities

NCT02234063 | Completed Results

• 1 other identifier: GCO 12-1143
• Study Type: interventional
• Target: 2,052
• Locations: 1 country
• Sites: 2

Brief Summary

In this genomic medicine implementation pilot project, the investigators aim to conduct a randomized trial in a network of community health centers and primary care facilities to study processes, effects and challenges of incorporating information for apolipoprotein L1 (APOL1)-attributable genetic risk for end stage kidney disease in patients of African ancestry with hypertension .

Conditions

Hypertension; Chronic Kidney Disease; Genomics

Keywords

Hypertension; Chronic Kidney Disease; End Stage Renal Disease; APOL1; Genomics; Genetics; Community-engaged

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Urine Protein Excretion

  Number of participants with urine protein excretion in urine tests to assess kidney function at 12 months as compared to baseline

  Baseline and 12 months

• Change in Systolic Blood Pressure

  Change in systolic blood pressure at 3 months as compared to baseline

  Baseline and 3 months

Secondary Outcomes (3)

• Number of Participants With Change in Medication Adherence

  3 months

• Number of Patients With Changes in Psychosocial Behaviors

  3 months

• Number of Participants With Attitude Towards Genetic Testing

  3 months

Study Arms (2)

Immediate Genetic Testing

EXPERIMENTAL

Participants randomized to intervention will receive the APOL1 genetic test upon study enrollment.

Other: Immediate Genetic Testing

Control- Delayed Testing

NO INTERVENTION

Participants randomized to control will not receive the APOL1 genetic test upon study enrollment. They will be offered the option to take the test during their final follow-up study visit (12 months post enrollment).

Interventions

Immediate Genetic Testing OTHER

Participants will receive the APOL1 genetic test. Trained research staff will meet with participants to communicate results and lifetime ESRD risk attributable to variations in the APOL1 gene. Primary care providers will receive APOL1 genetic risk information via a best practice alert in the participant's EMR upon commencement of a patient encounter and through results filed in the participant's genetics results section of their EMR.

Also known as: Genetic Risk Communication

Immediate Genetic Testing

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages18-65
• Self-identifies as Black/African American
• History of hypertension
• Patient at a participating site

You may not qualify if:

• History of Chronic Kidney Disease
• History of Diabetes
• Pregnant
• Cognitively impaired/unable to provide consent
• Terminally ill
• Planning to leave area of study permanently during the one year study period

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (2)

Institute for Family Health

New York, New York, 10006, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Nadkarni GN, Fei K, Ramos MA, Hauser D, Bagiella E, Ellis SB, Sanderson S, Scott SA, Sabin T, Madden E, Cooper R, Pollak M, Calman N, Bottinger EP, Horowitz CR. Effects of Testing and Disclosing Ancestry-Specific Genetic Risk for Kidney Failure on Patients and Health Care Professionals: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e221048. doi: 10.1001/jamanetworkopen.2022.1048.

  PMID: 35244702 DERIVED

Related Links

• Implementing GeNomics In PracTicE (IGNITE) Network Website

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Primary analysis was conducted on the Genotype level and not on the randomization level.

Results Point of Contact

• Title: Dr. Carol R. Horowitz
• Organization: Icahn School of Medicine at Mount Sinai

carol.horowitz@mssm.edu

212-659-9564

Study Officials

• Erwin Bottinger, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Carol R Horowitz, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 9, 2014
• Study Start: November 1, 2014
• Primary Completion: January 12, 2018
• Study Completion: January 12, 2018
• Last Updated: October 5, 2020
• Results First Posted: October 5, 2020

Record last verified: 2020-09

Locations

US (2)