Primary Renal AllograftPhase 4NCT00374647
Study to Evaluate Safety and Efficacy of Early Calcineurin Inhibitor Withdrawal in Primary Renal Allografts
A Phase 4 study testing mycophenolate mofetil and sirolimus in people with Primary Renal Allograft, run by University of Cincinnati at 2 sites in United States.
Trial summary
Evaluate the safety and efficacy of early corticosteroid withdrawal and simultaneous calcineurin inhibitor withdrawal in recipients of primary renal allografts maintained long-term on MMF and sirolimus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Renal Allograft
- What is being tested?
- mycophenolate mofetil and sirolimus
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2005to Dec 2007
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients between 18 and 75 years of age.
- Patients who are 90 to 240 days after having received a primary living or cadaver renal allograft.
- Patients maintained on a regimen of cyclosporine or tacrolimus and MMF since transplantation.
- Capable of providing written informed consent.
- No known contraindications to treatment with sirolimus.
Who cannot join
- Pregnant or lactating.
- Acute rejection within 90 days prior to study randomization.
- More than one biopsy proven acute rejection episode prior to study randomization.
- Previously received or are receiving an organ transplant other than kidney.
- Receiving sirolimus prior to entry.
- Severe diarrhea or other gastrointestinal disorders that may interfere with their ability to absorb oral medication.
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- Evidence of active systemic infection requiring antibiotics, or HIV, HCV, HBV infection.
- History of malignancy in the past 5 years.
- Require dialysis at the time of study entry.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Christ Hospital
Cincinnati, Ohio, 45267
University of Cincinnati
Cincinnati, Ohio, 45267
About this study
Official title: Open Label Randomized Single Study to Evaluate the Safety & Efficacy of Early CNI Withdrawal in Recipients of Primary Renal Allografts Maintained Long-Term on Mycophenolate Mofetil; MMF (CellCept) and Sirolimus (Rapamune)
Evaluate the safety and efficacy of early corticosteroid withdrawal and simultaneous calcineurin inhibitor withdrawal in recipients of primary renal allografts maintained long-term on MMF and sirolimus.
- Conditions
- Primary Renal Allograft
- Being tested
- mycophenolate mofetil, sirolimus
- Keywords
- Renal, Kidney, Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sirolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of either acute rejection, biopsy proven calcineurin inhibitor toxicity, or failure of the estimated BSA indexed GFR by MDRD method to improve by 20% from time randomization to 12 months.
Secondary outcomes (6)
Renal allograft function at 6 and 12 months.
Incidence of biopsy proven acute rejection at 6 and 12 months.
Time to first rejection.
Total number of rejection episodes per patient.
Graft loss and patient death.
Incidence of treatment failure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2006 (estimated)
- Study startMar 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Renal AllograftStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E. Steve Woodle, University of Cincinnati
- Investigators
- Steve Woodle, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374647
- Sponsor's protocol ID
- STN INV INT
- Status last verified
- Jul 2021
- First submitted
- 8 Sep 2006
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Randomized Single Study to Evaluate the Safety & Efficacy of Early CNI Withdrawal in Recipients of Primary Renal Allografts Maintained Long-Term on Mycophenolate Mofetil; MMF (CellCept) and Sirolimus (Rapamune)
- ClinicalTrials.gov ID
- NCT00374647
- Acronym / sponsor ID
- STN INV INT
- Conditions
- Primary Renal Allograft
- Keywords
- Renal, Kidney, Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 11 Sep 2006 (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.
Evaluate the safety and efficacy of early corticosteroid withdrawal and simultaneous calcineurin inhibitor withdrawal in recipients of primary renal allografts maintained long-term on MMF and sirolimus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients between 18 and 75 years of age.
- Patients who are 90 to 240 days after having received a primary living or cadaver renal allograft.
- Patients maintained on a regimen of cyclosporine or tacrolimus and MMF since transplantation.
- Capable of providing written informed consent.
- No known contraindications to treatment with sirolimus.
Key exclusion criteria (9 listed)
- Pregnant or lactating.
- Acute rejection within 90 days prior to study randomization.
- More than one biopsy proven acute rejection episode prior to study randomization.
- Previously received or are receiving an organ transplant other than kidney.
- Receiving sirolimus prior to entry.
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 |
|---|---|---|
| mycophenolate mofetil | Drug | – |
| sirolimus | Drug | – |
Primary outcome
Composite endpoint of either acute rejection, biopsy proven calcineurin inhibitor toxicity, or failure of the estimated BSA indexed GFR by MDRD method to improve by 20% from time randomization to 12 months.
6 secondary outcomes
Renal allograft function at 6 and 12 months.
Incidence of biopsy proven acute rejection at 6 and 12 months.
Time to first rejection.
Total number of rejection episodes per patient.
Graft loss and patient death.
Incidence of treatment failure.
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 Jul 2021.
Related trials for Primary Renal Allograft
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RecruitingPhase 4
Evaluation of the Efficacy of a Treatment by One Single Dose of Rituximab (375mg/m2 ) in the Prevention of the Epstein Barr Virus (EBV) Primary Infection and Post-transplant Lymphoproliferative Disorder in Adult EBV Seronegative Patients Who Received an EBV Seropositive Kidney Allograft
Epstein-Barr Virus Infections
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.
Steve Woodle, MD principal investigator
University of Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mycophenolate mofetil and sirolimus in people with Primary Renal Allograft, run by University of Cincinnati at 2 sites 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 5 inclusion and 9 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 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Composite endpoint of either acute rejection, biopsy proven calcineurin inhibitor toxicity, or failure of the estimated BSA indexed GFR by MDRD method to improve by 20% from time randomization to 12 months.. 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 15 Jul 2021.