An Open, Single Centre, Randomised, Parallel Group Study to Investigate Three Different Immunosuppressive Regimens (SterFreePlus)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 If no rejection is detected the calcineurin inhibitor (tacrolimus) is withdrawn.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 If no rejection is detected the calcineurin inhibitor (tacrolimus) is withdrawn.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 If no rejection is detected prednisone is withdrawn.
Condition | Intervention | Phase |
---|---|---|
Comparative Study Immunosuppressive Agents |
Drug: Rapamycin Drug: Everolimus Drug: Prednisone |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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 |
- Plasma creatinine and creatinine clearance (Cockcroft-Gault) after 6 months of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Enrollment: | 63 |
Study Start Date: | July 2008 |
Study Completion Date: | June 2010 |
Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Comparator: Rapamycin
Rapamycin-MMF-tacrolimus
|
Drug: Rapamycin
Add rapamycin de novo to tacrolimus and MMF
Other Name: Sirolimus
|
Active Comparator: Everolimus
Everolimus - tacrolimus - MMF
|
Drug: Everolimus
Add everolimus de novo to tacrolimus and MMF
|
Active Comparator: Prednisone
tacrolimus - MMF -prednisone
|
Drug: Prednisone
Add prednisone de novo to tacrolimus and MMF
|
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Switzerland | |
Clinic for transplantation immunology and nephrology | |
Basel, Switzerland, 4031 |
Principal Investigator: | Juerg U Steiger, Professor | University Hospital, Basel, Switzerland |
No publications provided
Responsible Party: | Juerg Steiger, professor, clinic for transplantation immunology and nephrology, university hospital Basel |
ClinicalTrials.gov Identifier: | NCT01183247 History of Changes |
Other Study ID Numbers: | 187/07 |
Study First Received: | August 16, 2010 |
Last Updated: | August 16, 2010 |
Health Authority: | Switzerland: Swissmedic |
Keywords provided by University Hospital, Basel, Switzerland:
Everolimus, rapamycin, prednisone, tacrolimus, |
MMF, steroid-free, protocol biopsy |
Additional relevant MeSH terms:
Immunosuppressive Agents Sirolimus Everolimus Tacrolimus Prednisone Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Glucocorticoids Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents Antibiotics, Antineoplastic Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on October 17, 2012