Kidney TransplantPhase 4NCT00223678
Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure
A Phase 4 study testing Rapamycin in people with Kidney Transplant, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
A study to determine the effect on renal function in renal transplant patients with biopsy proven Chronic allograft nephropathy (CAN) nephropathy who are switched from a Calcinerin inhibitor (CI) triple drug regimen to a Rapamycin based triple drug regimen or maintained on their CI protocol Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Rapamycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2000to Oct 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is the recipient of a cadaveric or living donor renal transplant.
- Patient was > 12 years of age at the time of transplant.
- Patient is at least 3 months post-transplant.
- Patient has been on a calcineurin inhibitor based immunosuppression since the transplant.
- Patient has one of the following risk factors for chronic renal allograft failure:
- Serum creatinine > 2.0 mg/dL 3 months or later post-transplant in males patients.
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- Serum creatinine > 1.7 mg/dL 3 months or later post-transplant in female patients.
- Serum > 30% increased over post discharge nadir.
- Patients had a renal biopsy that shows chronic allograft nephropathy.
- Patient or legal guardian had signed and dated an Institutional Review Board (IRB) approved informed consent document and is willing and able to follow study procedures.
- If female and of child bearing potential, patient has a negative pregnancy test and agrees to practice effective birth control while receiving mycophenolate mofetil (MMF), Rapamycin and other immunosuppressants.
- -
Who cannot join
- Patient is the recipient of a solid organ transplant other than the kidney.
- Patient is dialysis dependent.
- Patient has recurrence of primary renal disease, or de novo renal disease.
- Patient has an estimated creatinine clearance <25ml/min calculated using the Cockcroft/Gault formula.
- Patient has changed maintenance immunosuppressant therapy (e.g., azathioprine to MMF) within three months of randomization.
- Baseline biopsy shows acute rejection Banff Grade > Class 2 (IIB).
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- Patient required anti-lymphocyte therapy to treat rejection found on baseline biopsy.
- Patient has received an investigational immunosuppressant within three months.
- Patient is pregnant or lactating.
- Patient is a known carrier of any of the HIV viruses.
- Patient has known hypersensitivity to Rapamycin, or any of the excipients of the drug.
Trial locations and contacts
1 site in 1 country.
About this study
A study to determine the effect on renal function in renal transplant patients with biopsy proven Chronic allograft nephropathy (CAN) nephropathy who are switched from a Calcinerin inhibitor (CI) triple drug regimen to a Rapamycin based triple drug regimen or maintained on their CI protocol
- Conditions
- Kidney Transplant
- Being tested
- Rapamycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapamycinDrug
Also called Sirolimus
Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin Receives: Drug: Rapamycin |
| 2 | No intervention | Patient will remain on calcineruin inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2000
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Vanderbilt University 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Langone, Vanderbilt University Medical Center
- Investigators
- Anthony Langone, M.D., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223678
- Sponsor's protocol ID
- 000294
- Status last verified
- May 2017
- First submitted
- 19 Sep 2005
- Last updated
- 21 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure
- ClinicalTrials.gov ID
- NCT00223678
- Acronym / sponsor ID
- 000294
- Conditions
- Kidney Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jun 2000
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 6 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to determine the effect on renal function in renal transplant patients with biopsy proven Chronic allograft nephropathy (CAN) nephropathy who are switched from a Calcinerin inhibitor (CI) triple drug regimen to a Rapamycin based triple drug regimen or maintained on their CI protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Rapamycinpt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin |
| 2 | No intervention | –Patient will remain on calcineruin inhibitor |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Patient is the recipient of a cadaveric or living donor renal transplant.
- Patient was > 12 years of age at the time of transplant.
- Patient is at least 3 months post-transplant.
- Patient has been on a calcineurin inhibitor based immunosuppression since the transplant.
- Patient has one of the following risk factors for chronic renal allograft failure:
Key exclusion criteria (11 listed)
- Patient is the recipient of a solid organ transplant other than the kidney.
- Patient is dialysis dependent.
- Patient has recurrence of primary renal disease, or de novo renal disease.
- Patient has an estimated creatinine clearance <25ml/min calculated using the Cockcroft/Gault formula.
- Patient has changed maintenance immunosuppressant therapy (e.g., azathioprine to MMF) within three months of randomization.
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 |
|---|---|---|
| RapamycinAlso: SirolimusRapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15 | Drug | 1 |
Primary outcome
Graft Survival
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Anthony Langone, M.D. principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rapamycin in people with Kidney Transplant, run by Vanderbilt University 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 12 inclusion and 11 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 21 Jun 2017. 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. 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?
Yes. Results are posted in the registry (first posted 6 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Graft Survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2017.