Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306397
Status:
COMPLETED
Last Update Posted:
2010-06-30
First Post:
2006-03-22
Brief Title:
Pilot Study to Investigate a Steroid Free Immunosuppressive Regimen for Renal Transplant Recipients
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 11 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Patients successfully withdrawn from calcineurin inhibitor at three months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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004DR3379 | None | None | None |