Clinical trial NCT00306397: Pilot Study to Investigate a Steroid Free Immunosuppressive Regimen for Renal Transplant Recipients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: Kidney transplantation
Steroid free
Calcineurin inhibitor free
Tacrolimus
Sirolimus
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2006-03-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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* Patients successfully withdrawn from calcineurin inhibitor at three months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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* patients with a low or high immunological risk constellation

Primary outcomes:
measure: Allograft function
timeFrame: 6 months
Secondary outcomes:
measure: Patients successfully withdrawn from calcineurin inhibitor after three months
timeFrame: 3 months
measure: Graft survival
timeFrame: 6 months
measure: Patient survival
timeFrame: 6 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Clinic for Transplantation Immunology and Nephrology
Study officials:
affiliation: University Hospital Basel, Clinic for Transplantation Immunology and Nephrology
name: Juerg U Steiger, MD
role: PRINCIPAL_INVESTIGATOR
References: