Phase 3
Completed N=852
Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy
Source: ClinicalTrials.gov NCT01120028 ↗Enrolled (actual)
852
Serious AEs
77.8%
Results posted
Oct 2019
Primary outcomePrimary: Number of Participants With Biopsy-proven Acute Rejection at 6-months After Randomization to Induction Therapy — 31; 68 Participants — p=<0.0001
◆ Published Evidence
Highly cited
148citations · ~12 / year
Alemtuzumab-based induction treatment versus basiliximab-based induction treatment in kidney transplantation (the 3C Study): a randomised trial.
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.
Linked Publications (3)
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Alemtuzumab-based induction treatment versus basiliximab-based induction treatment in kidney transplantation (the 3C Study): a randomised trial.
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Campath, calcineurin inhibitor reduction, and chronic allograft nephropathy (the 3C Study) - results of a randomized controlled clinical trial.
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Campath, calcineurin inhibitor reduction and chronic allograft nephropathy (3C) study: background, rationale, and study protocol.
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 |
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) and the linked publication. 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.