High Blood PressurePhase 4NCT00140907
ALLOGRAFT, A Study to Evaluate the Renal Protective Effects of Losartan (0954-222)(COMPLETED)
A Phase 4 study testing losartan potassium in people with High Blood Pressure, run by Organon and Co.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- losartan potassium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 367 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2000to 1 Jan 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
Official title: A Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Renal Protective Effects of Losartan in Patients With Renal Transplant
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
- Being tested
- losartan potassium, Comparator: Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: Comparator: Placebo |
| 2 | Active comparator | Losartan Receives: Drug: losartan potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chronic allograft nephropathy
Measured: 24 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study start14 Mar 2000
- Primary completion1 Jan 2005
- Study completion1 Jan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140907
- Sponsor's protocol ID
- 0954-222
- Other IDs
- MK0954-222, 2005_053
- Status last verified
- Feb 2022
- First submitted
- 30 Aug 2005
- Last updated
- 15 Aug 2024
- Results posted
- No
Publications
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.
PubMed 39082471
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Renal Protective Effects of Losartan in Patients With Renal Transplant
- ClinicalTrials.gov ID
- NCT00140907
- Acronym / sponsor ID
- 0954-222
- Conditions
- High Blood Pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2000 (actual)
- Primary completion
- 1 Jan 2005 (actual)
- Study completion
- 1 Jan 2005 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Comparator: PlaceboPlacebo |
| 2 | Active comparator | Drug: losartan potassiumLosartan |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| losartan potassium25 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. | Drug | 2 |
| Comparator: Placebo25 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. | Drug | 1 |
Primary outcome
Incidence of chronic allograft nephropathy
Time frame: 24 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Derived from this study: PubMed 39082471Natale 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing losartan potassium in people with High Blood Pressure, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of chronic allograft nephropathy (time frame: 24 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00140907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.