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Pilot Study to Investigate a Steroid Free Immunosuppressive Regimen for Renal Transplant Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00306397
First Posted: March 23, 2006
Last Update Posted: June 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Basel, Switzerland
  Purpose
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.

Condition Intervention Phase
Kidney Transplantation Drug: Rapamycin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Allograft function [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Patients successfully withdrawn from calcineurin inhibitor after three months [ Time Frame: 3 months ]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 ]

Enrollment: 100
Study Start Date: January 2005
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Rapamycin - MMF after 3 months
Drug: Rapamycin
Sirolimus perorally following kidney transplantation, randomisation after protocol biopsy at months three to a) Sirolimus - MF- or b) low dose tacrolimus - sirolimus -MMF -
Other Names:
  • Sirolimus
  • Rapammune
Active Comparator: B
Low dose tacrolimus - MMF - Rapamycin after 3 months
Drug: Rapamycin
Sirolimus perorally following kidney transplantation, randomisation after protocol biopsy at months three to a) Sirolimus - MF- or b) low dose tacrolimus - sirolimus -MMF -
Other Names:
  • Sirolimus
  • Rapammune

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306397


Locations
Switzerland
University Hospital Basel, Clinic for Transplantation Immunology and Nephrology
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Juerg U Steiger, MD University Hospital Basel, Clinic for Transplantation Immunology and Nephrology
  More Information

Responsible Party: Steiger Juerg / Professor, University Hospital Basel, Clinic for transplantation immunology and nephrology
ClinicalTrials.gov Identifier: NCT00306397     History of Changes
Other Study ID Numbers: CERL-080-CH02
2004DR3379
First Submitted: March 22, 2006
First Posted: March 23, 2006
Last Update Posted: June 30, 2010
Last Verified: June 2010

Keywords provided by University Hospital, Basel, Switzerland:
Kidney transplantation
Steroid free
Calcineurin inhibitor free
Tacrolimus
Sirolimus

Additional relevant MeSH terms:
Tacrolimus
Sirolimus
Everolimus
Immunosuppressive Agents
Calcineurin Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents