Tacrolimus monotherapy for low risk kidney transplant recipients.

Registry ID
EUCTR2014-001372-66
Source registry
EUCTR
Status
Ongoing
Phase
PHASE2
Sponsor
Erasmus Medical Center
Start date
2014-07-08
Last update
2026-08-16

Conditions

Summary

Feasibility objectives: 1. Methodology: Outcome in the control group: what is the BPAR-rate in the control group? 2. Process: Consent rates. How many patients can be included, what is the rate of consent, determining centre willingness and capacity? 3. Scientific (biological plausibility): The primary objective of the pilot study is to estimate the treatment effect using surrogate endpoints with the following immunological parameters: I. Detection of total alloreactive T-cell compartment by CD137+ T staining. II. Leucocyte subsets. III. In vivo assessment of general immune responses: - Vaccination responses: Tetanus, pneumococcus, influenza. IV. The incidence of infection as measured by: a. detection of polyoma BK viral load in serum. b. detection of CMV viral load in serum. c. hospital admission for infection-related problems. d. antibiotic prescriptions (treatment episode defined as 5 or more consecutive days of antibiotic treatment).

Locations

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