Phase 3
Completed N=56
Induction Therapy Study in Live Donor Kidney Transplant Recipients With a Positive Crossmatch
Kidney Failure, Chronic
Source: ClinicalTrials.gov NCT00275509 ↗
Enrolled (actual)
56
Serious AEs
26.8%
Results posted
Dec 2017
Primary outcomePrimary: 6-month Acute Cellular-mediated Rejection Rate (CMR) — 14; 20 Participants
Summary
The purpose of this study is to determine whether the anti-T cell antibody, Thymoglobulin is a more effective induction medication than the anti-IL-2R inhibitor daclizumab, in kidney transplant recipients who have a positive crossmatch with their live donor.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6-month Acute Cellular-mediated Rejection Rate (CMR) |
14; 20 | — |
| PRIMARY 6-month Acute Antibody-mediated Rejection Rate (AMR) |
17; 16 | — |
| PRIMARY 6-month Cumulative Rejection Incidence (Either CMR, AMR or Both) |
21; 23 | — |
Eligibility Criteria
Inclusion Criteria
- Adult (18 years or older)
- End-stage renal disease
- Identified to have positive lymphocytotoxic crossmatch or flow cytometric crossmatch with live donor
Exclusion Criteria
- Deceased donor recipients
- Pregnancy
- Active infection
- History of cancer within the past two years (with the exception of non-melanomatous skin cancer)
- History of heparin induced thrombocytopenia
- Medical contraindications to transplant procedure
Data sourced from ClinicalTrials.gov (NCT00275509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.