ALLOGRAFT, A Study to Evaluate the Renal Protective Effects of Losartan (0954-222)(COMPLETED)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00140907
• Collaborator: (none)
• Enrollment: 367
• Arms: 2
• Actual Duration (Months): 57.6

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
High Blood Pressure	Drug: losartan potassium; Drug: Comparator: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 367 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Actual Study Start Date: Mar 14, 2000
• Actual Primary Completion Date: Jan 1, 2005
• Actual Study Completion Date: Jan 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Incidence of chronic allograft nephropathy [24 months post treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00140907
• Other Study ID Numbers: 0954-222; MK0954-222; 2005_053
• First Posted: Sep 1, 2005
• Last Update Posted: Feb 16, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Hypertension; Losartan

Study Results

No Results Posted as of Feb 16, 2022