Prevention of Kidney Transplant Rejection

NCT00005010 | Completed Phase 3 DMC

• 1 other identifier: DAIT CR01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see how effective 2 drugs, irbesartan and pravastatin, are at slowing kidney transplant failure. Many kidney transplant patients have some type of chronic rejection. Chronic rejection is a disease that causes scarring and damage to the kidney. Over time, chronic rejection can lead to kidney failure, making it necessary for patients to start dialysis and possibly receive another kidney transplant. Doctors would like to see whether irbesartan and pravastatin can slow this damage and prevent kidney failure in patients with signs of chronic rejection.

Conditions

End-Stage Renal Disease; Chronic Allograft Nephropathy

Outcome Measures

Primary Outcomes (1)

• death, or renal failure manifested by initiation of dialysis or retransplantation.

  Randomization to End of Study

Interventions

Irbesartan DRUG

Pravastatin DRUG

Eligibility Criteria

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

You may qualify if:

• You may be eligible for this study if you:
• Are at least 18 years old.
• Received a kidney transplant at least 1 year prior to study entry.
• Have been diagnosed with chronic rejection following kidney transplant and within 6 months prior to study entry.
• Have been receiving a stable immunosuppressive medication regimen for 1 month prior to study entry that includes at least cyclosporine or tacrolimus and prednisone.
• Have high blood pressure.
• Agree to use an effective method of birth control during the study.

You may not qualify if:

• You will not be eligible for this study if you:
• Are participating in another study with required tests or treatments.
• Cannot take ACE inhibitors or HMG-CoA reductase inhibitors.
• Absolutely must take ACE inhibitors or HMG-CoA reductase inhibitors.
• Have a serious disease or medical condition.
• Are pregnant.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Ilene Blechman-Krom

Rockville, Maryland, 20850, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Irbesartan; Pravastatin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Naphthalenes; Polycyclic Aromatic Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2000
• First Posted: August 31, 2001
• Study Completion: March 1, 2004
• Last Updated: January 25, 2013

Record last verified: 2013-01

Locations

US (1)