Comparative StudyPhase 4SterFreePlusNCT01183247
An Open, Single Centre, Randomised, Parallel Group Study to Investigate Three Different Immunosuppressive Regimens
A Phase 4 study testing Rapamycin, Everolimus and Prednisone in people with Comparative Study and Immunosuppressive Agents, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
An open, single center, randomised study to investigate three different immunosuppressive regimens for de novo renal transplant recipients: 1. st sirolimus / EC-MPS / tacrolimus regimen After 3 months a protocol biopsy is performed. If no rejection is detected the calcineurin inhibitor (tacrolimus) is withdrawn. 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Comparative Study, Immunosuppressive Agents
- What is being tested?
- Rapamycin, Everolimus and Prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2008to Jun 2010
- 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 or female patients between 18 and 75 years of age, regardless of race.
- Female patients of child bearing age agree to maintain effective birth control practice during the study.
- Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation as assessed by the transplantation centre.
- Patient has been fully informed and has given written or independent person witnessed oral informed consent.
Who cannot join
- in Patient is pregnant or breastfeeding.
- Patient has a low immunological risk constellation, defined by receiving a kidney from a HLA-identical related living donor.
- Patient has a high immunological risk constellation, defined as having donor specific HLA-antibodies and/or having a previous graft survival shorter than 3 years due to rejection.
- Patient and donor have a positive T or B-cell crossmatch.
- Patient and donor are ABO incompatible.
- Age of donor > 75 years.
Show all 17Show fewer
- Cold ischemia time > 36 hours.
- Patient has leucopenia, defined as having at transplantation less than 3000/mm3 leukocytes.
- Patient has thrombocytopenia, defined as having at transplantation less than 75000/mm3 thrombocytes.
- Patient is allergic or intolerant to cremophor RH 60 or structurally related compounds, steroids, everolimus, tacrolimus, Sirolimus or EC-MPS.
- Patient or donor is known to be HIV positive.
- Patient has significant liver disease, defined as having during the past 28 days continuously ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3 fold of the upper value of the normal range of the investigational site.
- Patient with malignancy or history of malignancy ≤ 2 years, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
- Patient has significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, or active peptic ulcer.
- Patient is taking or has been taking an investigational drug in the past 28 days.
- Patient has previously received or is receiving another organ transplant other than kidney.
- Patient is unlikely to comply with the visits schedule the protocol.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic for transplantation immunology and nephrology
Basel, 4031
About this study
Official title: An Open, Single Centre, Randomised, Parallel Group Study to Investigate Three Different Immunosuppressive Regimens for de Novo Renal Transplant Recipients: A Comparison of a Sirolimus / EC-MPS (Myfortic) / Tacrolimus Regimen, an Everolimus / EC-MPS / Tacrolimus Regimen and a EC-MPS / Tacrolimus Prednisone Regimen
An open, single center, randomised study to investigate three different immunosuppressive regimens for de novo renal transplant recipients:
- st sirolimus / EC-MPS / tacrolimus regimen
- After 3 months a protocol biopsy is performed. If no rejection is detected the calcineurin inhibitor (tacrolimus) is withdrawn.
- nd everolimus / EC-MPS / tacrolimus regimen
- After 3 months a protocol biopsy is performed. If no rejection is detected the calcineurin inhibitor (tacrolimus) is withdrawn.
- rd tacrolimus / EC-MPS / prednisone regimen - After 3 months a protocol biopsy is performed. If no rejection is detected prednisone is withdrawn.
Read the detailed description
This study is designed to show similar efficacy but a different adverse event profile between the three regimens. Its main purpose is to provide more information, if steroid free immunosuppressive treatment is a valuable alternative in the treatment of de novo kidney transplant recipients and that it is possible to withdraw calcineurin inhibitors after 3 months in this steroid free protocol. A secondary rationale of the study is to compare sirolimus with everolimus directly to better differentiate these two mTOR-inhibitors in terms of compound-specific effects and class-effects. This should allow for early conclusions on the usage of these two mTOR-inhibitors in CNI-free regimens.
Basis for this study are the following hypotheses regarding the first 6 months of treatment following kidney transplantation:
- Similar graft function in the three treatment groups after 6 months
- No difference in graft and patient survival in the three groups
- No differences in incidence of first, total number, type of acute rejections, and number of anti-rejection treatments in the three groups
- No differences in number of patients successfully withdrawn from calcineurin inhibitor in the sirolimus and everolimus arm, respectively
- A different adverse event profile with regard to the incidence of dyslipidemias, impaired fasting glucose, new onset diabetes mellitus, de novo post-transplant insulin dependency, histological signs of calcineurin inhibitor toxicity, and tubulointerstitial nephrotoxicity in the three groups. In addition to this the incidence of mTOR-inhibitor specific adverse events will be analysed.
These hypotheses are the basis for the study objectives.
- Conditions
- Comparative Study, Immunosuppressive Agents
- Being tested
- Rapamycin, Everolimus, Prednisone
- Keywords
- Everolimus,, rapamycin,, prednisone,, tacrolimus,, MMF,, steroid-free,, protocol biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapamycinDrug
Also called Sirolimus
Add rapamycin de novo to tacrolimus and MMF
EverolimusDrug
Add everolimus de novo to tacrolimus and MMF
PrednisoneDrug
Add prednisone de novo to tacrolimus and MMF
| Study group | Role | What they receive |
|---|---|---|
| Rapamycin | Active comparator | Rapamycin-MMF-tacrolimus Receives: Drug: Rapamycin |
| Everolimus | Active comparator | Everolimus - tacrolimus - MMF Receives: Drug: Everolimus |
| Prednisone | Active comparator | tacrolimus - MMF -prednisone Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma creatinine and creatinine clearance (Cockcroft-Gault) after 6 months of treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startJul 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparative StudyStudies 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
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Juerg U Steiger, Professor, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183247
- Sponsor's protocol ID
- 187/07
- Acronym
- SterFreePlus
- Status last verified
- Aug 2010
- First submitted
- 16 Aug 2010
- Last updated
- 17 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single Centre, Randomised, Parallel Group Study to Investigate Three Different Immunosuppressive Regimens for de Novo Renal Transplant Recipients: A Comparison of a Sirolimus / EC-MPS (Myfortic) / Tacrolimus Regimen, an Everolimus / EC-MPS / Tacrolimus Regimen and a EC-MPS / Tacrolimus Prednisone Regimen
- ClinicalTrials.gov ID
- NCT01183247
- Acronym / sponsor ID
- SterFreePlus / 187/07
- Conditions
- Comparative Study, Immunosuppressive Agents
- Keywords
- Everolimus,, rapamycin,, prednisone,, tacrolimus,, MMF,, steroid-free,, protocol biopsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jul 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 17 Aug 2010 (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.
An open, single center, randomised study to investigate three different immunosuppressive regimens for de novo renal transplant recipients:
- st sirolimus / EC-MPS / tacrolimus regimen
- After 3 months a protocol biopsy is performed. If no rejection is detected the calcineurin inhibitor (tacrolimus) is withdrawn.
- nd everolimus / EC-MPS / tacrolimus regimen
- After 3 months a protocol biopsy is performed. If no rejection is detected the calcineurin inhibitor (tacrolimus) is withdrawn.
- rd tacrolimus / EC-MPS / prednisone regimen - After 3 months a protocol biopsy is performed. If no rejection is detected prednisone is withdrawn.
Detailed description
This study is designed to show similar efficacy but a different adverse event profile between the three regimens. Its main purpose is to provide more information, if steroid free immunosuppressive treatment is a valuable alternative in the treatment of de novo kidney transplant recipients and that it is possible to withdraw calcineurin inhibitors after 3 months in this steroid free protocol. A secondary rationale of the study is to compare sirolimus with everolimus directly to better differentiate these two mTOR-inhibitors in terms of compound-specific effects and class-effects. This should allow for early conclusions on the usage of these two mTOR-inhibitors in CNI-free regimens.
Basis for this study are the following hypotheses regarding the first 6 months of treatment following kidney transplantation:
- Similar graft function in the three treatment groups after 6 months
- No difference in graft and patient survival in the three groups
- No differences in incidence of first, total number, type of acute rejections, and number of anti-rejection treatments in the three groups
- No differences in number of patients successfully withdrawn from calcineurin inhibitor in the sirolimus and everolimus arm, respectively
- A different adverse event profile with regard to the incidence of dyslipidemias, impaired fasting glucose, new onset diabetes mellitus, de novo post-transplant insulin dependency, histological signs of calcineurin inhibitor toxicity, and tubulointerstitial nephrotoxicity in the three groups. In addition to this the incidence of mTOR-inhibitor specific adverse events will be analysed.
These hypotheses are the basis for the study objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rapamycin | Active comparator | Drug: RapamycinRapamycin-MMF-tacrolimus |
| Everolimus | Active comparator | Drug: EverolimusEverolimus - tacrolimus - MMF |
| Prednisone | Active comparator | Drug: Prednisonetacrolimus - MMF -prednisone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients between 18 and 75 years of age, regardless of race.
- Female patients of child bearing age agree to maintain effective birth control practice during the study.
- Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation as assessed by the transplantation centre.
- Patient has been fully informed and has given written or independent person witnessed oral informed consent.
Key exclusion criteria (17 listed)
- in Patient is pregnant or breastfeeding.
- Patient has a low immunological risk constellation, defined by receiving a kidney from a HLA-identical related living donor.
- Patient has a high immunological risk constellation, defined as having donor specific HLA-antibodies and/or having a previous graft survival shorter than 3 years due to rejection.
- Patient and donor have a positive T or B-cell crossmatch.
- Patient and donor are ABO incompatible.
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: SirolimusAdd rapamycin de novo to tacrolimus and MMF | Drug | Rapamycin |
| EverolimusAdd everolimus de novo to tacrolimus and MMF | Drug | Everolimus |
| PrednisoneAdd prednisone de novo to tacrolimus and MMF | Drug | Prednisone |
Primary outcome
Plasma creatinine and creatinine clearance (Cockcroft-Gault) after 6 months of treatment
Time frame: 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 17 Aug 2010.
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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.
Juerg U Steiger, Professor principal investigator
University Hospital, Basel, Switzerland
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, Everolimus and Prednisone in people with Comparative Study and Immunosuppressive Agents, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 17 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 17 Aug 2010. 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 Switzerland. 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?
Plasma creatinine and creatinine clearance (Cockcroft-Gault) after 6 months of treatment (time frame: 6 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 17 Aug 2010.