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

NCT ID: NCT00306397

Last Updated: 2010-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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* Patients successfully withdrawn from calcineurin inhibitor at three months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.

Conditions

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Kidney Transplantation

Keywords

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Kidney transplantation Steroid free Calcineurin inhibitor free Tacrolimus Sirolimus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

Rapamycin - MMF after 3 months

Group Type ACTIVE_COMPARATOR

Rapamycin

Intervention Type DRUG

Sirolimus perorally following kidney transplantation, randomisation after protocol biopsy at months three to a) Sirolimus - MF- or b) low dose tacrolimus - sirolimus -MMF -

B

Low dose tacrolimus - MMF - Rapamycin after 3 months

Group Type ACTIVE_COMPARATOR

Rapamycin

Intervention Type DRUG

Sirolimus perorally following kidney transplantation, randomisation after protocol biopsy at months three to a) Sirolimus - MF- or b) low dose tacrolimus - sirolimus -MMF -

Interventions

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Rapamycin

Sirolimus perorally following kidney transplantation, randomisation after protocol biopsy at months three to a) Sirolimus - MF- or b) low dose tacrolimus - sirolimus -MMF -

Intervention Type DRUG

Other Intervention Names

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Sirolimus Rapammune

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Basel, Clinic for transplantation immunology and nephrology

Principal Investigators

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Juerg U Steiger, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Clinic for Transplantation Immunology and Nephrology

Locations

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University Hospital Basel, Clinic for Transplantation Immunology and Nephrology

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2004DR3379

Identifier Type: -

Identifier Source: secondary_id

CERL-080-CH02

Identifier Type: -

Identifier Source: org_study_id