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Efficacy and Safety of Sirolimus in Combination With Tacrolimus

NCT ID: NCT00141804

Last Updated: 2005-12-01

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2005-06-30

Brief Summary

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To study the efficacy and safety of the administration of Tacrolimus in combination with Sirolimus for the prevention of acute rejection in patients after renal transplantation

Detailed Description

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Basic randomized clinical trial (multicentre) in primary KTX to assess the safety and efficacy of a tac/rapa vs a tac/MMF regimen. Tac trough levels in accordance with current standards in both arms. Steroids to be used to individual centre protocol. Rapa trough levels will be adjusted to 5-10 ng/ml. Up to now only few data (primate and clinical) on tac/rap combinations available.

Conditions

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Kidney Transplantation

Keywords

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renal transplantation immunosuppression prevention of acute rejection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Sirolimus

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* first kidney transplantation
* re-transplantation
* non-related living donor transplantation
* patients \> 18 years
* patients have given their written consent after being informed
* female patients in the age of parity must consent to an effective birth control and submit a negative pregnancy test

Exclusion Criteria

* related living donation
* patients with known HIV-anamnesis
* patients who need systemically administered immunosuppression for another indication than the prophylaxis of kidney graft rejection
* patients with present malignant disease
* patients with clinically significant, uncontrolled infectional disease and/or severe diarrhea, vomiting or active gastric ulcer
* patients who haven taken part in a clinical study in the past 28 days and/or receive (received) medication which is not licensed by the responsible health authority
* other reasons which depend on the assessment of the physician
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Proverum GmbH

UNKNOWN

Sponsor Role collaborator

KKS Netzwerk

NETWORK

Sponsor Role collaborator

Fujisawa GmbH

INDUSTRY

Sponsor Role collaborator

University Hospital Muenster

OTHER

Sponsor Role lead

Principal Investigators

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Heiner H. Wolters, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Muenster

Locations

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University Hospital Muenster

Münster, , Germany

Site Status

Countries

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Germany

Other Identifiers

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contract number DE-02-RG-74

Identifier Type: -

Identifier Source: secondary_id

SirTac 01

Identifier Type: -

Identifier Source: org_study_id