Sirolimus Based Immunosuppression for Patients Undergoing Kidney Transplantation in the Eurotransplant Senior Program

Outcome After Renal Transplantation of a Randomized Prospective Trial in the Eurotransplant Senior Program

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00461357

Acronym

ESP

Enrollment

Registered

2007-04-18

Start date

2003-01-31

Completion date

2007-12-31

Last updated

2007-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Function After Transplantation, Outcome After Kidney Transplantation

Keywords

Old for Old, Eurotransplant Senior Program, Glomerular Filtration Rate

Brief summary

The Eurotransplant Senior Program (ESP) started in 1999 with local allocation of kidneys from deceased donors elder than 65 years to recipients elder than 65 years. The requirements for immunosuppression in this group of patients are high due to the large amount of comorbidities. This prospective randomized trial compared the standard immunosuppressive protocol based on cyclosporine A (CyA) used at our center within the ESP, to a calcineurin inhibitor-free protocol based on sirolimus (SRL). The aim of this study is to investigate the effect of a CNI-free therapy on the function of elderly kidneys 6 months post transplantation, measured by GFR.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* Recipients of the Eurotransplant Senior Program * negative cytotoxic crossmatch * signed informed consent

Exclusion criteria

* High sensitized recipients (PRA \> 40%) * Non heart Beating Donor * Hyperlipidemia * Leucocytopenia (\< 3000/mm3) * Thrombocytopenia (\< 75000/mm3)

Outcome results