Phase 3
N=852
Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy
Kidney Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT01120028 ↗Enrolled (actual)
852
Serious AEs
77.8%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants With Biopsy-proven Acute Rejection at 6-months After Randomization to Induction Therapy — 31; 68 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Alemtuzumab (Drug); Basiliximab (Drug); Sirolimus (Drug); Tacrolimus (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Oxford
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Biopsy-proven Acute Rejection at 6-months After Randomization to Induction Therapy |
31; 68 | <0.0001 sig |
| PRIMARY Graft Function (at 18-months After Randomization to Maintenance Therapy) |
53.7; 54.6 | 0.5 |
| SECONDARY Number of Participants With Graft Failure (at 6-months After Randomization to Induction Therapy) |
16; 13 | 0.58 |
| SECONDARY Number of Participants With Graft Failure (at 18-Months After Randomization to Maintenance Therapy) |
8; 4 | 0.23 |
| SECONDARY Number of Participants With Serious Infection (at 6-months After Randomization to Induction Therapy) |
135; 136 | 0.88 |
| SECONDARY Number of Participants With Serious Infection (at 18-months After Randomization to Maintenance Therapy) |
95; 70 | 0.008 sig |
| SECONDARY Number of Participants With Cancer (at 18-months After Randomization to Maintenance Therapy) |
17; 17 | 0.99 |
| SECONDARY Number of Participants With Major Vascular Event (at 18-months After Randomization to Maintenance Therapy) |
10; 13 | 0.52 |
Summary
The 3C study is investigating whether reducing exposure to calcineurin inhibitors (by using more potent antibody induction treatment and/or an elective switch to sirolimus) can improve the function and survival of kidney transplants.
Eligibility Criteria
Inclusion Criteria
- men or women aged over 18 years
- recipient of kidney transplant (planned in next 24 hours)
Exclusion Criteria
- recipients of multi-organ transplant
- previous treatment with Campath-1H
- active infection (including HIV, hepatitis B or C)
- history of anaphylaxis to humanized monoclonal antibody
- history of malignancy (except adequately treated non-melanoma skin cancer)
- loss of kidney transplant within 6 months not due to technical reasons
- medical history that might limit the individual's ability to take trial treatments for the duration of the study
Data sourced from ClinicalTrials.gov (NCT01120028). 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.