Phase 2
N=29
"A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation"
Renal Transplant
Bottom Line
View on ClinicalTrials.gov: NCT00365846 ↗Enrolled (actual)
29
Serious AEs
67.9%
Results posted
Jul 2012
Primary outcome: Primary: Incidence of Allograft Rejection — 13 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Campath-1H (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Jul 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Allograft Rejection |
13 | — |
| SECONDARY Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment) |
6 | — |
| SECONDARY Patient Survival |
28 | — |
| SECONDARY Incidence of Post-transplant Infection |
28 | — |
| SECONDARY Incidence of Malignancies |
2 | — |
| SECONDARY Kidney Allograft Survival |
27 | — |
Summary
The purpose of the study is to see if campath-1H can be used in first time renal transplant subjects to prevent rejection and reduce the overall amount of anti-rejection medications that patients take on a daily basis.
Eligibility Criteria
Inclusion Criteria
- primary renal transplant (not HLA identical)
- ages 18-60 years
Exclusion Criteria
- recipient panel reactive antibody level >10%
- recipient of a DCD kidney
- no prior organ transplant
- no multi-organ transplant recipient
- no subject who is currently receiving systemic corticosteroids
- no pregnant or lactating subjects
- no history of Hepatitis B, C or HIV positivity
- no recipient of a kidney with cold ischemia time >36 hours
Data sourced from ClinicalTrials.gov (NCT00365846). 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.