Back to resultsCalcineurin Free Immunosuppression in Renal Transplant Recipients
Primary Purpose
Kidney Transplantation, Chronic Kidney Disease
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Sirolimus
Cyclosporine A
Prednisone
Mycophenolate mofetil
Protocol biopsies
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Transplantation focused on measuring kidney transplantation, calcineurin inhibitor free, protocol biopsy, Cyclosporin A, Sirolimus
Eligibility Criteria
Inclusion Criteria:
- Male or female patients between 15 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 center.
- Patient has been fully informed and has given written or independent person witnessed oral informed consent.
Exclusion Criteria:
- 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 within the previous three years a measured PRA grade of ≥25% 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 > 68 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, Cyclosporine A Neoral, Rapamycin or MMF.
- Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s).
- 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 in the protocol.
Sites / Locations
- University Hospital Basel, Clinic for Transplantation Immunology and Nephrology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Calcineurin free
Calcineurin
Arm Description
Immunosuppression with Sirolimus, Mycophenolate and Steroids
Immunosuppressive therapy with Cyclosporin A, Mycophenolate and Steroids
Outcomes
Primary Outcome Measures
Plasma Creatinine
Secondary Outcome Measures
Graft survival
Patient survival
Incidence of first acute rejections and number of total rejections
Total number of anti-rejection treatments
Full Information
NCT ID
NCT00812123
First Posted
December 18, 2008
Last Updated
December 18, 2008
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00812123
Brief Title
Calcineurin Free Immunosuppression in Renal Transplant Recipients
Official Title
Open, Single Center, Randomised, Parallel Group Pilot Study to Investigate a Calcineurin Free Immunosuppressive Treatment for de Novo Renal Transplant Recipients: A Comparison of a Rapamycin/MMF/Steroids Regime to a Cyclosporine A Neoral/MMF/Steroids Regimen in the Prevention of Acute Rejection Following Renal Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to obtain preliminary information on the efficacy, safety and cost of two regimens, Rapamycin / MMF / steroid therapy and Cyclosporine A Neoral / MMF / steroid therapy, used in the prevention of acute rejection following renal transplantation.
Detailed Description
This pilot study is designed to show differences in efficacy, safety and cost between the two regimens. Its main purpose is to provide information, if calcineurin free immunosuppressive treatment is a valuable alternative in the treatment of de novo kidney transplant recipients. Furthermore, by investigating the side effects in both arms it will be possible to decide, if the absence of calcineurin inhibition and lack of nephrotoxicity will outweigh the adverse effects of Rapamycin. With the obtained information it will be possible to plan a larger trial, which is warranted to compare the mentioned treatment regimens in more detail.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation, Chronic Kidney Disease
Keywords
kidney transplantation, calcineurin inhibitor free, protocol biopsy, Cyclosporin A, Sirolimus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calcineurin free
Arm Type
Experimental
Arm Description
Immunosuppression with Sirolimus, Mycophenolate and Steroids
Arm Title
Calcineurin
Arm Type
Active Comparator
Arm Description
Immunosuppressive therapy with Cyclosporin A, Mycophenolate and Steroids
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Other Intervention Name(s)
Rapamune
Intervention Description
Loading dose 30 mg for three days, trough level of 10-20 ng/ml month 1-3, 8-15 ng/ml month 4 - 6
Intervention Type
Drug
Intervention Name(s)
Cyclosporine A
Other Intervention Name(s)
Sandimmun neoral
Intervention Description
Loading dose of 300 mg for three days, trough levels 250-300 ng/ml months 1-3, 150-250 ng/ml months 4 to 6
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
0.5 mg/kg, tapering every two weeks until 0.1 mg/kg
Intervention Type
Drug
Intervention Name(s)
Mycophenolate mofetil
Other Intervention Name(s)
CellCept
Intervention Description
2 x 1000mg, through level above 2ug/ml
Intervention Type
Procedure
Intervention Name(s)
Protocol biopsies
Intervention Description
protocol kidney biopsies at month one and three
Primary Outcome Measure Information:
Title
Plasma Creatinine
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Graft survival
Time Frame
6 months
Title
Patient survival
Time Frame
6 months
Title
Incidence of first acute rejections and number of total rejections
Time Frame
6 months
Title
Total number of anti-rejection treatments
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients between 15 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 center.
Patient has been fully informed and has given written or independent person witnessed oral informed consent.
Exclusion Criteria:
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 within the previous three years a measured PRA grade of ≥25% 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 > 68 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, Cyclosporine A Neoral, Rapamycin or MMF.
Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s).
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 in the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürg U Steiger, MD
Organizational Affiliation
Clinic for Transplantation Immunology and Nephrology, University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel, Clinic for Transplantation Immunology and Nephrology
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
19926370
Citation
Franz S, Regeniter A, Hopfer H, Mihatsch M, Dickenmann M. Tubular toxicity in sirolimus- and cyclosporine-based transplant immunosuppression strategies: an ancillary study from a randomized controlled trial. Am J Kidney Dis. 2010 Feb;55(2):335-43. doi: 10.1053/j.ajkd.2009.09.004. Epub 2009 Nov 17.
Results Reference
derived
Learn more about this trial
Calcineurin Free Immunosuppression in Renal Transplant Recipients
We'll reach out to this number within 24 hrs