Kidney TransplantationPhase 4NCT00306397
Pilot Study to Investigate a Steroid Free Immunosuppressive Regimen for Renal Transplant Recipients
A Phase 4 study testing Rapamycin in people with Kidney Transplantation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The main purpose of this study is to investigate, whether a steroid free immunosuppressive treatment is a valuable alternative in the treatment of de novo kidney transplant recipients and if it is possible to withdraw calcineurin inhibitors after 3 months. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Rapamycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2005to Dec 2008
- 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
- adult patients with end stage kidney disease suitable for primary renal transplantation or retransplantation
- patients receiving a graft from a living related, living unrelated or brain-death donor
Who cannot join
- patients with a low or high immunological risk constellation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Clinic for Transplantation Immunology and Nephrology
Basel, 4031
About this study
Official title: Open, Single Centre, Pilot Study to Investigate a Steroid Free Immunosuppressive Regimen for De Novo Renal Transplant Recipients Followed by Randomisation to Calcineurin Inhibitor Containing or Calcineurin Inhibitor Free Immunosuppression
The main purpose of this study is to investigate, whether a steroid free immunosuppressive treatment is a valuable alternative in the treatment of de novo kidney transplant recipients and if it is possible to withdraw calcineurin inhibitors after 3 months.
Read the detailed description
Protocol synopsis Title An open, single centre, pilot study to investigate a steroid free immunosuppressive regimen for de novo renal transplant recipients followed by a two arm randomization to a calcineurin inhibitor containing and a calcineurin inhibitor free maintenance immunosuppression after three months. Study code Sterfree pilot study Project phase An open, single centre, one arm study followed by a 1:1 randomized, parallel group, comparative study after three months. Study objectives To obtain preliminary information on the efficacy and safety of a rapamycin / sodium-mycophenolate (Myfortic) / tacrolimus regimen in the absence of steroids for the prevention of acute rejection following renal transplantation. To compare a low dose tacrolimus / rapamycin / sodium-mycophenolate (Myfortic) regimen to a rapamycin / sodium-mycophenolate regimen in patients without evidence of acute rejection after three months.
Efficacy:
Primary endpoint
- Plasma creatinine (and creatinine clearance (Cockcroft)) Secondary endpoints
- Incidence of first acute rejections and total number of acute rejections
- Total number of anti-rejection treatments
- Patients successfully withdrawn from calcineurin inhibitor at three months
- Graft survival
- Patient survival
Safety:
- Graft survival
- Patient survival
- Protocol biopsies at 3 months( range: day 75 to 105) and 6 months (range day 165 to 195) sub clinical rejection
- Incidence of first acute biopsy proven rejection and total number of acute rejection episodes
- Total number of anti-rejection treatments
- Patients switched from assigned therapy due to rejection or side effects
- Patients needing steroids because of rejection
- Incidence of selected adverse events: tubulointerstitial nephrotoxicity (TOR inhibitor), leucopenia, thrombocytopenia, elevated fasting blood glucose, dyslipidemia, , electrolyte disturbances, de novo insulin dependency, gastrointestinal disorders (non infectious), neurotoxicity.
- Patients withdrawn due to adverse events
Long term patient follow up Patients will be followed up for graft and patient survival at 12, 24, and 36 months post-transplantation.
- Conditions
- Kidney Transplantation
- Being tested
- Rapamycin
- Keywords
- Kidney transplantation, Steroid free, Calcineurin inhibitor free, Tacrolimus, Sirolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapamycinDrug
Also called Sirolimus, Rapammune
Sirolimus perorally following kidney transplantation, randomisation after protocol biopsy at months three to a) Sirolimus - MF- or b) low dose tacrolimus - sirolimus -MMF -
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Rapamycin - MMF after 3 months Receives: Drug: Rapamycin |
| B | Active comparator | Low dose tacrolimus - MMF - Rapamycin after 3 months Receives: Drug: Rapamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allograft function
Measured: 6 months
Secondary outcomes (3)
Patients successfully withdrawn from calcineurin inhibitor after three months
Measured: 3 months
Graft survival
Measured: 6 months
Patient survival
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 posted23 Mar 2006 (estimated)
- Study startJan 2005
- Primary completionJun 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Juerg U Steiger, MD, Principal investigator, University Hospital Basel, Clinic for Transplantation Immunology and Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306397
- Sponsor's protocol ID
- CERL-080-CH02
- Other IDs
- 2004DR3379
- Status last verified
- Jun 2010
- First submitted
- 22 Mar 2006
- Last updated
- 30 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Single Centre, Pilot Study to Investigate a Steroid Free Immunosuppressive Regimen for De Novo Renal Transplant Recipients Followed by Randomisation to Calcineurin Inhibitor Containing or Calcineurin Inhibitor Free Immunosuppression
- ClinicalTrials.gov ID
- NCT00306397
- Acronym / sponsor ID
- CERL-080-CH02
- Conditions
- Kidney Transplantation
- Keywords
- Kidney transplantation, Steroid free, Calcineurin inhibitor free, Tacrolimus, Sirolimus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 23 Mar 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.
The main purpose of this study is to investigate, whether a steroid free immunosuppressive treatment is a valuable alternative in the treatment of de novo kidney transplant recipients and if it is possible to withdraw calcineurin inhibitors after 3 months.
Detailed description
Protocol synopsis Title An open, single centre, pilot study to investigate a steroid free immunosuppressive regimen for de novo renal transplant recipients followed by a two arm randomization to a calcineurin inhibitor containing and a calcineurin inhibitor free maintenance immunosuppression after three months. Study code Sterfree pilot study Project phase An open, single centre, one arm study followed by a 1:1 randomized, parallel group, comparative study after three months. Study objectives To obtain preliminary information on the efficacy and safety of a rapamycin / sodium-mycophenolate (Myfortic) / tacrolimus regimen in the absence of steroids for the prevention of acute rejection following renal transplantation. To compare a low dose tacrolimus / rapamycin / sodium-mycophenolate (Myfortic) regimen to a rapamycin / sodium-mycophenolate regimen in patients without evidence of acute rejection after three months.
Efficacy:
Primary endpoint
- Plasma creatinine (and creatinine clearance (Cockcroft)) Secondary endpoints
- Incidence of first acute rejections and total number of acute rejections
- Total number of anti-rejection treatments
- Patients successfully withdrawn from calcineurin inhibitor at three months
- Graft survival
- Patient survival
Safety:
- Graft survival
- Patient survival
- Protocol biopsies at 3 months( range: day 75 to 105) and 6 months (range day 165 to 195) sub clinical rejection
- Incidence of first acute biopsy proven rejection and total number of acute rejection episodes
- Total number of anti-rejection treatments
- Patients switched from assigned therapy due to rejection or side effects
- Patients needing steroids because of rejection
- Incidence of selected adverse events: tubulointerstitial nephrotoxicity (TOR inhibitor), leucopenia, thrombocytopenia, elevated fasting blood glucose, dyslipidemia, , electrolyte disturbances, de novo insulin dependency, gastrointestinal disorders (non infectious), neurotoxicity.
- Patients withdrawn due to adverse events
Long term patient follow up Patients will be followed up for graft and patient survival at 12, 24, and 36 months post-transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: RapamycinRapamycin - MMF after 3 months |
| B | Active comparator | Drug: RapamycinLow dose tacrolimus - MMF - Rapamycin after 3 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients with end stage kidney disease suitable for primary renal transplantation or retransplantation
- patients receiving a graft from a living related, living unrelated or brain-death donor
Key exclusion criteria (1 listed)
- patients with a low or high immunological risk constellation
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: Sirolimus, RapammuneSirolimus perorally following kidney transplantation, randomisation after protocol biopsy at months three to a) Sirolimus - MF- or b) low dose tacrolimus - sirolimus -MMF - | Drug | A, B |
Primary outcome
Allograft function
Time frame: 6 months
3 secondary outcomes
Patients successfully withdrawn from calcineurin inhibitor after three months
Time frame: 3 months
Graft survival
Time frame: 6 months
Patient survival
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 30 Jun 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, MD principal investigator
University Hospital Basel, Clinic for Transplantation Immunology and Nephrology
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 Transplantation, 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 2 inclusion and 1 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 30 Jun 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?
Allograft function (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 30 Jun 2010.