Pilot Study to Investigate a Steroid Free Immunosuppressive Regimen for Renal Transplant Recipients - Full Text View

Sponsored by:	University Hospital, Basel, Switzerland
Information provided by:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00306397

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 IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

Primary Outcome Measures:

Allograft function [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patients successfully withdrawn from calcineurin inhibitor after three months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Graft survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Patient survival [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	January 2005
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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 -
B: Active Comparator 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 -

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 rapamycine / 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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306397

Contacts

Contact: Juerg U Steiger, MD	+41 61 265 44 04	jsteiger@uhbs.ch
Contact: Michael Dickenmann, MD	+41 61 265 44 39	mdickenmann@uhbs.ch

Locations

Switzerland
University Hospital Basel, Clinic for Transplantation Immunology and Nephrology	Recruiting
Basel, Switzerland, 4031
Contact: Juerg U Steiger, MD +41 61 265 44 04 jsteiger@uhbs.ch
Contact: Michael Dickenmann, MD +41 61 265 44 39 mdickenmann@uhbs.ch
Principal Investigator: Juerg U Steiger, MD

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

No publications provided

Responsible Party:	University Hospital Basel, Clinic for transplantation immunology and nephrology ( Steiger Juerg / Professor )
Study ID Numbers:	CERL-080-CH02, 2004DR3379
Study First Received:	March 22, 2006
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00306397 History of Changes
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:

Kidney transplantation
Steroid free
Calcineurin inhibitor free
Tacrolimus
Sirolimus

Study placed in the following topic categories:

Sirolimus
Anti-Bacterial Agents
Immunologic Factors
Clotrimazole
Miconazole

Antifungal Agents
Tioconazole
Tacrolimus
Immunosuppressive Agents

Additional relevant MeSH terms:

Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Antifungal Agents

Therapeutic Uses
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009