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

Organon

Status and phase

Completed

Phase 4

Conditions

High Blood Pressure

Treatments

Drug: losartan potassium

Drug: Comparator: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00140907

0954-222

2005_053

MK0954-222

Details and patient eligibility

About

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

Enrollment

367 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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