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

NCT ID: NCT00140907

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 367 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-03-14
• Study Completion Date: 2005-01-01

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

Conditions

High Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Placebo

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type: DRUG

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.

2

Losartan

Group Type: ACTIVE_COMPARATOR

losartan potassium

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.

Reference Type: DERIVED

PMID: 39082471 (View on PubMed)

Other Identifiers

MK0954-222

Identifier Type: -

Identifier Source: secondary_id

2005_053

Identifier Type: -

Identifier Source: secondary_id

0954-222

Identifier Type: -

Identifier Source: org_study_id