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Efficacy and Safety of Sirolimus in Combination With Tacrolimus

U

University Hospital Muenster

Status and phase

Unknown
Phase 3

Conditions

Kidney Transplantation

Treatments

Drug: Sirolimus

Study type

Interventional

Funder types

Other
NETWORK
Industry

Identifiers

NCT00141804
SirTac 01
contract number DE-02-RG-74

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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