Renal TransplantPhase 1NCT00270153
The Use of ACE Inhibitors in the Early Renal Post-transplant Period
A Phase 1 study testing enalapril in people with Renal Transplant, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Chronic allograft nephropathy (CAN) is the leading cause of longterm renal transplant loss. Angiotensin-II may play a role in the development and progression of CAN. Angiotensin converting enzyme inhibitors (ACEI) comprise a drug class that inhibit the effects of angiotensin-II. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Renal Transplant
- What is being tested?
- enalapril
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Dec 2009
- Phase
- Phase 1
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New adult renal transplant recipients with good renal function defined as serum creatinine less than 2.6 mg/dl,
- Normal serum potassium levels,
- No contraindication to ACE inhibitor use
Who cannot join
- Renal transplant patients with persistent serum creatinine levels over 2.5 mg/dl
- Hyperkalemia with serum potassium levels over 5.5 mEQ/dl
- History of allergic reaction to ACE inhibitors or angiotensin receptor blockers
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467-2490
About this study
Chronic allograft nephropathy (CAN) is the leading cause of longterm renal transplant loss. Angiotensin-II may play a role in the development and progression of CAN. Angiotensin converting enzyme inhibitors (ACEI) comprise a drug class that inhibit the effects of angiotensin-II. However these drugs have been reported to cause elevated potassium and creatinine levels in some renal transplant patients. Yet, there are now several retrospective reports of long term benefits of improved renal function and graft survival in renal transplant recipients. There have been no reports of prospective randomized controlled trials of ACEI in renal transplant patients in the early post transplant period.
The purpose of the present study is to assess the safety of enalapril, a drug in the ACEI class, when started 1-3 month post transplant. This is a double-blinded, randomized control trial of enalapril vs. placebo in new renal transplant patients with serum creatinine values no higher than 2.5mg/dl and normal serum potassium levels. The study drug will be administered for 6 months. Patients will be monitored in the renal transplant clinic every 1-4 weeks according to routine protocol. Clinical end-points will be occurence of potassium >5.9mEQ/L or sustained increase in serum creatinine >30% from baseline.
Read the detailed description
All new renal transplant recipients with functioning allografts and serum creatinine less than 2.6 mg/dl within the first 3 month post transplant would be eligible for this study of the safety of enalapril 5 mg vs placebo. Patients with serum potassium persistently over 5.5 mEQ/L would be excluded. This is a double-blinded randomized control study. End-points of the study are a persistent rise in serum creatinine of >30% from baseline not otherwise explained by clinical evaluation, and persistent serum potassium >5.9mEQ/L. Study duration is 6 month. At the end of the study patients will be continued on ACEI if clinically stable
- Conditions
- Renal Transplant
- Being tested
- enalapril, Placebo
- Keywords
- renal transplant, ACE inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enalaprilDrug
5mg enalapril daily for 6 months
PlaceboDrug
5mg enalapril-matching placebo daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| enalapril | Placebo comparator | Not described Receives: Drug: enalapril |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum creatinine levels assessed at 6 months
Creatinine is a waste product that comes from the normal wear and tear on muscles of the body. It is excreted through the kidneys. High serum creatinine levels in the blood indicate that the kidneys aren't functioning properly. Increase in serum creatinine of 30% would be a safety concern and requires clinical management.
Measured: Baseline and 6 months
Changes in potassium levels assessed at 6 months
Potassium is a chemical that is critical to the function of nerve and muscle cells, including those in your heart. Potassium levels must be kept within a very narrow concentration range. High Potassium levels are a sign of worsening kidney function. An occurence of serum potassium greater than 5.9 mEq/L is a safety concern and requires clinical management.
Measured: Baseline and 6 months
Decrease in estimated glomerular filtration rate (eGFR) assessed at 6 months
eGFR is a number based on your blood test for creatinine, a waste product in your blood.It tells how well your kidneys are working. A normal eGFR is 60 or more. A 25 percent decrease in eGFR indicates that the kidneys may not be working well. This is a safety concern and requires clinical management.
Measured: Baseline and 6 months.
Secondary outcomes (4)
Cough due to drug intolerance assessed at 6 months
Cough experienced because of inability to tolerate the adverse effects of the medication
Measured: Baseline and 6 months
abdominal pain due to drug intolerance assessed at 6 months
Abdominal pain experienced because of inability to tolerate the adverse effects of the medication
Measured: Baseline and 6 months
Erythrocytosis assessed at 6 months
Erythrocytosis is a condition in which your body makes too many red blood cells (RBCs). Too many red blood cells can make your blood thicker than normal and lead to blood clots and other complications.
Measured: Baseline and 6 months
Leukopenia assessed at 6 months
Leukopenia is a decrease in the number of white blood cells found in the blood, which places individuals at increased risk of infection.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2005 (estimated)
- Study startSep 2004
- Primary completionDec 2009
- Study completionDec 2009
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 Renal TransplantStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Coco, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270153
- Sponsor's protocol ID
- 03-12-311
- Status last verified
- Feb 2019
- First submitted
- 23 Dec 2005
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of ACE Inhibitors in the Early Renal Post-transplant Period
- ClinicalTrials.gov ID
- NCT00270153
- Acronym / sponsor ID
- 03-12-311
- Conditions
- Renal Transplant
- Keywords
- renal transplant, ACE inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Sep 2004 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Dec 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.
Chronic allograft nephropathy (CAN) is the leading cause of longterm renal transplant loss. Angiotensin-II may play a role in the development and progression of CAN. Angiotensin converting enzyme inhibitors (ACEI) comprise a drug class that inhibit the effects of angiotensin-II. However these drugs have been reported to cause elevated potassium and creatinine levels in some renal transplant patients. Yet, there are now several retrospective reports of long term benefits of improved renal function and graft survival in renal transplant recipients. There have been no reports of prospective randomized controlled trials of ACEI in renal transplant patients in the early post transplant period.
The purpose of the present study is to assess the safety of enalapril, a drug in the ACEI class, when started 1-3 month post transplant. This is a double-blinded, randomized control trial of enalapril vs. placebo in new renal transplant patients with serum creatinine values no higher than 2.5mg/dl and normal serum potassium levels. The study drug will be administered for 6 months. Patients will be monitored in the renal transplant clinic every 1-4 weeks according to routine protocol. Clinical end-points will be occurence of potassium >5.9mEQ/L or sustained increase in serum creatinine >30% from baseline.
Detailed description
All new renal transplant recipients with functioning allografts and serum creatinine less than 2.6 mg/dl within the first 3 month post transplant would be eligible for this study of the safety of enalapril 5 mg vs placebo. Patients with serum potassium persistently over 5.5 mEQ/L would be excluded. This is a double-blinded randomized control study. End-points of the study are a persistent rise in serum creatinine of >30% from baseline not otherwise explained by clinical evaluation, and persistent serum potassium >5.9mEQ/L. Study duration is 6 month. At the end of the study patients will be continued on ACEI if clinically stable
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| enalapril | Placebo comparator | Drug: enalapril |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- New adult renal transplant recipients with good renal function defined as serum creatinine less than 2.6 mg/dl,
- Normal serum potassium levels,
- No contraindication to ACE inhibitor use
Key exclusion criteria (4 listed)
- Renal transplant patients with persistent serum creatinine levels over 2.5 mg/dl
- Hyperkalemia with serum potassium levels over 5.5 mEQ/dl
- History of allergic reaction to ACE inhibitors or angiotensin receptor blockers
- Pregnancy
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 |
|---|---|---|
| enalapril5mg enalapril daily for 6 months | Drug | enalapril |
| Placebo5mg enalapril-matching placebo daily for 6 months | Drug | Placebo |
Primary outcome
Changes in serum creatinine levels assessed at 6 months
Time frame: Baseline and 6 months
Creatinine is a waste product that comes from the normal wear and tear on muscles of the body. It is excreted through the kidneys. High serum creatinine levels in the blood indicate that the kidneys aren't functioning properly. Increase in serum creatinine of 30% would be a safety concern and requires clinical management.
Changes in potassium levels assessed at 6 months
Time frame: Baseline and 6 months
Potassium is a chemical that is critical to the function of nerve and muscle cells, including those in your heart. Potassium levels must be kept within a very narrow concentration range. High Potassium levels are a sign of worsening kidney function. An occurence of serum potassium greater than 5.9 mEq/L is a safety concern and requires clinical management.
Decrease in estimated glomerular filtration rate (eGFR) assessed at 6 months
Time frame: Baseline and 6 months.
eGFR is a number based on your blood test for creatinine, a waste product in your blood.It tells how well your kidneys are working. A normal eGFR is 60 or more. A 25 percent decrease in eGFR indicates that the kidneys may not be working well. This is a safety concern and requires clinical management.
4 secondary outcomes
Cough due to drug intolerance assessed at 6 months
Time frame: Baseline and 6 months
abdominal pain due to drug intolerance assessed at 6 months
Time frame: Baseline and 6 months
Erythrocytosis assessed at 6 months
Time frame: Baseline and 6 months
Leukopenia assessed at 6 months
Time frame: Baseline and 6 months
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 7 Feb 2019.
- 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.
Maria Coco, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing enalapril in people with Renal Transplant, run by Montefiore Medical Center at 1 site in United States.
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 3 inclusion and 4 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 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Changes in serum creatinine levels assessed at 6 months (time frame: Baseline and 6 months). The study lists 3 primary outcomes in all. 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 NCT00270153, 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 7 Feb 2019.