CNI Side EffectsPhase 1/2CNI-SparingNCT01062555
Calcineurin Inhibitor Sparing After Kidney Transplantation
A Phase 1/2 study testing Cyclosporine & Cellcept, Prograf & Cellcept and Low Dose CNI (Cyclosporine or FK) and Cellcept in people with CNI Side Effects, run by University of Minnesota at 1 site in United States.
Trial summary
Reducing drug side effects is a key issue in transplantation. One class of drugs commonly used, calcineurin inhibitors (CNIs), is associated with negative side effects, namely, toxicity to the transplanted kidney. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CNI Side Effects
- What is being tested?
- Cyclosporine & Cellcept, Prograf & Cellcept and Low Dose CNI (Cyclosporine or FK) and Cellcept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 527 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2006to 3 Apr 2014
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney Transplant Recipients > 18 years old
- First or Second Kidney Transplant only
Who cannot join
- Kidney Transplant Recipients < 18 years old
- Kidney Transplant Recipients who have a history of > 2 kidney transplants
- Kidney Transplant Recipients with an already functioning non-renal transplant
- Kidney Transplant Recipients who receive another organ simultaneously at the same time of their kidney transplant (example: Kidney/pancreas, kidney/liver)
- Non-skin malignancy with 2 years previous to enrollment
- Donor Specific Antibodies to kidney donor
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
Official title: Calcineurin-Sparing in a Steroid-free Maintenance Immunosuppression Protocol After Kidney Transplantation
Reducing drug side effects is a key issue in transplantation. One class of drugs commonly used, calcineurin inhibitors (CNIs), is associated with negative side effects, namely, toxicity to the transplanted kidney. In some patients, this toxicity is thought to be associated with loss of transplant function in those who have had their transplants for many years. The introduction of new immunosuppression medications however, has provided the opportunity to minimize or avoid CNIs, which may reduce the occurrence of toxicity to the kidney.
Read the detailed description
It is clear that minimizing the use of CNIs may be beneficial to some or all kidney transplant recipients. The purpose of this study is to determine whether minimization of these CNI drugs will improve patient survival rates and long-term kidney function.
If the subject agrees to participate in this research project, they will be randomly assigned to one of two different immunosuppression drug combinations. All of the drugs used in this study are standard FDA Approved immunosuppressive drugs currently in use by transplant patients. It is unclear however, which combination provides a better long-term outcome.
If after six months of being on the study the subject has not experienced a rejection episode that excludes them from participating in the second phase of this study, they will asked whether or not they would like to continue the study. If they decide to participate in Phase II, there will be another randomization to one of two different immunosuppression drug combinations. This will involve either being assigned to a group that will have their CNI dose lowered or a group that will have their CNI drug stopped and replaced with a non-CNI drug called Sirolimus. Phase II begins at 6 months post-transplant and a second consent will be obtained for those who participate in Phase II.
- Conditions
- CNI Side Effects
- Being tested
- Cyclosporine & Cellcept, Prograf & Cellcept, Low Dose CNI (Cyclosporine or FK) and Cellcept, Rapamune and Cellcept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine & CellceptDrug
Also called CSA, Gengraf, Neoral, Sandimmune, MMF, Mycophenolate Mofetil
Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
Prograf & CellceptDrug
Also called FK, Tacrolimus, MMF, Mycophenolate Mofetil
Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
Low Dose CNI (Cyclosporine or FK) and CellceptDrug
Also called Gengraf, Neoral, Sandimmune, Tacrolimus, Prograf, MMF
Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
Rapamune and CellceptDrug
Also called Sirolimus, MMF, Mycophenolate Mofetil
Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
| Study group | Role | What they receive |
|---|---|---|
| Phase I Arm 1 | Active comparator | CSA and MMF Receives: Drug: Cyclosporine & Cellcept |
| Phase I Arm 2 | Active comparator | FK and MMF Receives: Drug: Prograf & Cellcept |
| Phase II Arm 1 | Active comparator | Low CNI and MMF Receives: Drug: Low Dose CNI (Cyclosporine or FK) and Cellcept |
| Phase II Arm 2 | Active comparator | Rapa and MMF Receives: Drug: Rapamune and Cellcept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: The Minimization of Negative Side Effects - Patient Survival
The percentage of patients alive at 6 month post transplant.
Measured: 6 months
Phase II: The Minimization of Negative Side Effects - Patient Survival
The percentage of patients alive at 7 years post transplant or at the end of study activities. Not all participants completed 7-year follow-up.
Measured: up to 7 years
Phase I: The Minimization of Negative Side Effects - Graft Survival
Percent of participants at 6 months with a functioning graft (without graft failure).
Measured: 6 months
Phase II: The Minimization of Negative Side Effects - Graft Survival
The percentage of patients with a functioning graft (without graft failure) at 7 years post transplant or at the end of study activities. Not all participants completed 7-year follow-up.
Measured: up to 7 years
Phase I: Acute Rejection-Free Survival
Percent of participants at 6 months without acute rejection.
Measured: 6 months
Phase II: Acute Rejection-Free Survival
The percentage of patients without acute rejection at 7 years post transplant or at the end of study activities. Not all participants completed 7-year follow-up.
Measured: up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study start1 Oct 2006
- Primary completion3 Apr 2014
- Study completion3 Apr 2014
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 CNI Side EffectsStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 527 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, Wyeth is now a wholly owned subsidiary of Pfizer, Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Arthur Matas, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062555
- Sponsor's protocol ID
- 0604M85327
- Acronym
- CNI-Sparing
- Status last verified
- Nov 2020
- First submitted
- 3 Feb 2010
- Last updated
- 14 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcineurin-Sparing in a Steroid-free Maintenance Immunosuppression Protocol After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT01062555
- Acronym / sponsor ID
- CNI-Sparing / 0604M85327
- Conditions
- CNI Side Effects
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Roche Pharma AG, Wyeth is now a wholly owned subsidiary of Pfizer, Genzyme, a Sanofi Company
- Study start
- 1 Oct 2006 (actual)
- Primary completion
- 3 Apr 2014 (actual)
- Study completion
- 3 Apr 2014 (actual)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Posted 14 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reducing drug side effects is a key issue in transplantation. One class of drugs commonly used, calcineurin inhibitors (CNIs), is associated with negative side effects, namely, toxicity to the transplanted kidney. In some patients, this toxicity is thought to be associated with loss of transplant function in those who have had their transplants for many years. The introduction of new immunosuppression medications however, has provided the opportunity to minimize or avoid CNIs, which may reduce the occurrence of toxicity to the kidney.
Detailed description
It is clear that minimizing the use of CNIs may be beneficial to some or all kidney transplant recipients. The purpose of this study is to determine whether minimization of these CNI drugs will improve patient survival rates and long-term kidney function.
If the subject agrees to participate in this research project, they will be randomly assigned to one of two different immunosuppression drug combinations. All of the drugs used in this study are standard FDA Approved immunosuppressive drugs currently in use by transplant patients. It is unclear however, which combination provides a better long-term outcome.
If after six months of being on the study the subject has not experienced a rejection episode that excludes them from participating in the second phase of this study, they will asked whether or not they would like to continue the study. If they decide to participate in Phase II, there will be another randomization to one of two different immunosuppression drug combinations. This will involve either being assigned to a group that will have their CNI dose lowered or a group that will have their CNI drug stopped and replaced with a non-CNI drug called Sirolimus. Phase II begins at 6 months post-transplant and a second consent will be obtained for those who participate in Phase II.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase I Arm 1 | Active comparator | Drug: Cyclosporine & CellceptCSA and MMF |
| Phase I Arm 2 | Active comparator | Drug: Prograf & CellceptFK and MMF |
| Phase II Arm 1 | Active comparator | Drug: Low Dose CNI (Cyclosporine or FK) and CellceptLow CNI and MMF |
| Phase II Arm 2 | Active comparator | Drug: Rapamune and CellceptRapa and MMF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Kidney Transplant Recipients > 18 years old
- First or Second Kidney Transplant only
Key exclusion criteria (6 listed)
- Kidney Transplant Recipients < 18 years old
- Kidney Transplant Recipients who have a history of > 2 kidney transplants
- Kidney Transplant Recipients with an already functioning non-renal transplant
- Kidney Transplant Recipients who receive another organ simultaneously at the same time of their kidney transplant (example: Kidney/pancreas, kidney/liver)
- Non-skin malignancy with 2 years previous to enrollment
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 |
|---|---|---|
| Cyclosporine & CellceptAlso: CSA, Gengraf, Neoral, Sandimmune, MMF, Mycophenolate MofetilDose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs. | Drug | Phase I Arm 1 |
| Prograf & CellceptAlso: FK, Tacrolimus, MMF, Mycophenolate MofetilDose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs. | Drug | Phase I Arm 2 |
| Low Dose CNI (Cyclosporine or FK) and CellceptAlso: Gengraf, Neoral, Sandimmune, Tacrolimus, Prograf, MMFDose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs. | Drug | Phase II Arm 1 |
| Rapamune and CellceptAlso: Sirolimus, MMF, Mycophenolate MofetilDose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs. | Drug | Phase II Arm 2 |
Primary outcome
Phase I: The Minimization of Negative Side Effects - Patient Survival
Time frame: 6 months
The percentage of patients alive at 6 month post transplant.
Phase II: The Minimization of Negative Side Effects - Patient Survival
Time frame: up to 7 years
The percentage of patients alive at 7 years post transplant or at the end of study activities. Not all participants completed 7-year follow-up.
Phase I: The Minimization of Negative Side Effects - Graft Survival
Time frame: 6 months
Percent of participants at 6 months with a functioning graft (without graft failure).
Phase II: The Minimization of Negative Side Effects - Graft Survival
Time frame: up to 7 years
The percentage of patients with a functioning graft (without graft failure) at 7 years post transplant or at the end of study activities. Not all participants completed 7-year follow-up.
Phase I: Acute Rejection-Free Survival
Time frame: 6 months
Percent of participants at 6 months without acute rejection.
Phase II: Acute Rejection-Free Survival
Time frame: up to 7 years
The percentage of patients without acute rejection at 7 years post transplant or at the end of study activities. Not all participants completed 7-year follow-up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Arthur Matas, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cyclosporine & Cellcept, Prograf & Cellcept and Low Dose CNI (Cyclosporine or FK) and Cellcept in people with CNI Side Effects, run by University of Minnesota 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 2 inclusion and 6 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 14 Dec 2020. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 14 Dec 2020). 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?
Phase I: The Minimization of Negative Side Effects - Patient Survival (time frame: 6 months). The study lists 6 primary outcomes in all. 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 14 Dec 2020.