NCT00140907

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
367

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2000

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2000

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

4.8 years

First QC Date

August 30, 2005

Last Update Submit

August 13, 2024

Conditions

High Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Incidence of chronic allograft nephropathy

    24 months post treatment

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo

2

ACTIVE COMPARATOR

Losartan

Drug: losartan potassium

Interventions

losartan potassiumDRUG

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.

2
Comparator: PlaceboDRUG

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.

1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 39082471DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Losartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

March 14, 2000

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

August 15, 2024

Record last verified: 2022-02