ALLOGRAFT, A Study to Evaluate the Renal Protective Effects of Losartan

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00140907
First received: August 30, 2005
Last updated: February 17, 2009
Last verified: February 2009
  Purpose

To demonstrate that losartan (+ conventional therapy) compared to placebo (+ conventional therapy) will reduce the number of RT patients who experience histological lesions of chronic allograft nephropathy


Condition Intervention
High Blood Pressure
Drug: losartan potassium
Drug: Comparator: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Renal Protective Effects of Losartan in Patients With Renal Transplant

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Incidence of chronic allograft nephropathy [ Time Frame: 24 months post treatment ] [ Designated as safety issue: No ]

Enrollment: 367
Study Start Date: February 2000
Study Completion Date: January 2005
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: Comparator: Placebo
25 mg of oral placebo once daily, with an up-titration to 50 mg placebo once daily in later visits if serum creatinine did not increase more than 25%. Patients take medication in the morning.
Active Comparator: 2
Losartan
Drug: losartan potassium
25 mg of oral losartan once daily, with an up-titration to 50 mg of losartan once daily in later visits if serum creatinine did not increase more than 25%. Patients take medication in the morning.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients With End Stage Chronic Renal Failure, Four To Eight Week After Receiving A First Or A Second Renal Transplant From A Dead Donor. In The Case Of A Second Transplant The Survival Of The First Graft Must Has Been 6 Month Or More
  • Patients Must Have A Serum Creatinine * 2 At Visit 1 And 2. Results Must Be Within 25% Of Each Other. The Baseline Period May Be Extended Until Four More Weeks To Obtain An Additional Serum Creatinine If One Of The First Two Serum Creatinine Results Do Not Qualify
  • Patients With Hypertension Must Have A Sitting Blood Pressure < 200/110 Mmhg At The Time Of Randomization
  • Normotensive Patients Must Have A Sitting Systolic Blood Pressure >100 Mmhg At The Time Of Randomization

Exclusion Criteria:

  • Hyperimmunized Patients At The Transplant Time Or In The Previous 6 Month, With A Pra of 50 %
  • Patients With Evidence Of Advanced Liver Disease
  • Serum Potassium <3.5 Or >5.5 Meq/L
  • History Of Allergy To Losartan
  • Other Factors Which May Affect Participation (E.G., Significant Concurrent Or Life Limiting Disease Such As Cancer In The Last Five Year Except Skin Neoplasias, Mental Or Legal Incapacitation, Drug Or Alcohol Abuse Within The Last 2 Years, Extensive Travel Planned In The Next 3 Years, Investigative Drug Trial Within The Last 4 Weeks)
  • Patients With Disseminated Or Localized Active Infectious Disease, At The Time Of Transplant
  • Acute Graft Rejection In The Grade III Of Banff Classification
  • Patients With Double-Transplant (Reno-Pancreatic)
  • Patients With Heart Failure Or History Of Myocardial Infarction Requiring Ace Inhibitor Or Aiia Therapies. Presence Or Known History Of Hemodynamically Significant Obstructive Valvular Disease Or Hypertrophic Cardiomyopathy
  • Renal Graft Artery Stenosis. An Eco-Doppler Test Must Be Performed In Order To Exclude A Graft Artery Stenosis
  • Pregnant Or Nursing Women
  • Chronic Use Of Nsaids
  • Major Psychotropic Agents Such As Phenothiazines Are Not Permitted, Use Of Lithium Is Not Permitted
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140907

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00140907     History of Changes
Other Study ID Numbers: 2005_053, MK0954-222
Study First Received: August 30, 2005
Last Updated: February 17, 2009
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014