Clinical trial NCT00140907: ALLOGRAFT, A Study to Evaluate the Renal Protective Effects of Losartan (0954-222)(COMPLETED)
Official title: A Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Renal Protective Effects of Losartan in Patients With Renal Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: High Blood Pressure
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Incidence of chronic allograft nephropathy
timeFrame: 24 months post treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: