Efficacy and Safety of Sirolimus in Combination With Tacr... | NCT00141804

Studies
Efficacy and Safety of Sirolimus in Combination With Tacrolimus

NCT00141804

Sponsor

University Hospital Muenster

Status

Unknown status

Last Update Posted

Dec 1, 2005Estimated

Enrollment

190

Phase

Phase 3

Conditions

Kidney Transplantation

Interventions

Sirolimus

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
contract number DE-02-RG-74

Status Module

Record Verification Date

Aug 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Not provided

Completion Date

Jun 2005

First Submitted Date

Aug 31, 2005

First Submission Date that Met QC Criteria

Aug 31, 2005

First Posted Date

Sep 1, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2005

Last Update Posted Date

Dec 1, 2005Estimated

Name	Class
Proverum GmbH	UNKNOWN
KKS Netzwerk	NETWORK
Fujisawa GmbH	INDUSTRY

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

190

Name	Type	Description	Arm Group Labels	Other Names
Sirolimus	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
- time to first biopsy proven acute rejection episode at month 12
- graft failure at month 12
- discontinuation of study medication at month 12

Secondary Outcomes

Measure	Description	Time Frame
- patient and graft survival at month 12
- incidence and severity of biopsy proven acute rejection episodes and incidence of steroid-resistant acute rejection episodes at month 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Heiner H. Wolters, Dr. med.	University Hospital Muenster	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Muenster		Münster		48149	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D020123	Sirolimus

Ancestor Terms

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided