N/A
N=40
Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation
Primary Renal Transplant
Bottom Line
View on ClinicalTrials.gov: NCT00214201 ↗Enrolled (actual)
40
Serious AEs
47.5%
Results posted
Sep 2012
Primary outcome: Primary: Number of Participants With Biopsy Proven Rejection — 2; 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Calcineurin inhibitor withdrawal (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Biopsy Proven Rejection |
2; 7 | — |
| SECONDARY Serum Creatinine at 36 Months (End of Study) |
1.49; 1.37 | — |
Summary
The purpose of this study is to determine whether Campath-1H induction therapy and the associated lymphocyte depletion will permit long-term, rejection free renal allograft function in the absence of maintenance calcineurin inhibitor (CI) therapy.
Eligibility Criteria
Inclusion Criteria
- received a renal transplant, induction with Campath-1H, and at least 2 months of calcineurin inhibitor therapy, CellCept, and prednisone.
Exclusion Criteria
- Recipients of HLA-identical living-donor renal transplants;
- PRA value >20% within 30 days of transplant;
- GFR <40ml/min;
- multi-organ transplant;
Data sourced from ClinicalTrials.gov (NCT00214201). 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.