Renal transplantation. MedDRA version: 14.1 Level: LLT Classification code 10023438 Term: Kidney transplant System Organ Class: 100000004865
Conditions
Interventions
Trade Name: MabCampath
Product Name: Campath-1H
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Alemtuzumab
CAS Number: 216503-57-0
Other descriptive name: Campath-1H
C
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: INDUCTION THERAPY RANDOMISATION INCLUSION CRITERIA: - age 18 or over; - scheduled to receive kidney transplant in next 24 hours - negative pregnancy test (if female and able to pass urine [not required if unable to pass urine as per standard practice]). MAINTENANCE THERAPY INCLUSION CRITERIA (at 6 months after transplantation): - patient and managing doctors remain willing to randomise between tacrolimus- and sirolimus-based maintenance therapy Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: INDUCTION THERAPY EXCLUSION CRITERIA: - planned multi-organ transplant - previous treatment with Campath - active infection - history of anaphylaxis with humanized monoclonal antibodies - history of malignancy (with exception of adequately-treated non-melanoma skin cancer) - loss of previous transplant within 6 months not due to technical reasons - medical history that might limit the patient's ability to take trial treatments for the duration of the study MAINTENANCE THERAPY EXCLUSION CRITERIA (at 6 months after transplantation): - biopsy-proven acute rejection (Banff grade >1) within one month - proteinuria >800 mg/day (or urinary protein:creatinine ratio >80)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aims of the 3C Study are to investigate, in people receiving a kidney transplant, whether: 1) using Campath-1H as induction therapy (i.e. given around the time of transplant surgery) reduces the incidence of acute rejection of the kidney transplant at 6 months after surgery, compared to standard basiliximab-based induction therapy; and 2) whether sirolimus-based maintenance immunosuppression (i.e. the drugs they have to take every day to prevent their body's immune system from attacking ('rejecting') the transplant) improves the function of their kidney transplant, compared to using tacrolimus-based maintenance therapy at 2 years after transplantation.;Secondary Objective: The secondary objectives of the 3C study are to investigate in people receiving a kidney tranplant: 1) whether the use of Campath-1H induction therapy (i.e. given around the time of transplant surgery) improves the long-term function and survival of the transplant, compared to using standard induction therapy; 2) whether Campath-1H has a similar safety profile to standard induction therapy (e.g. number and/or severity of infections, malignancy, patient survival) 3) whether using sirolimus as maintenance therapy improves the long-term survival of the transplant, compared to using standard maintenance therapy 4) whether sirolimus has a similar safety profile to standard maintenance therapy (similar to (2) above) In addition a health economic analysis will be performed to estimate the average costs and effectiveness within each study arm, and incremental cost-effectiveness of CAMPATH induction compared to basiliximab induction, and of sirolimus-based maintenance therapy compared to;Primary end point(s): There are two primary outcomes: (i) effect of Campath-1H on the incidence of acute rejection at six months post-transplantation; and (ii) effect of sirolimus on transplant function (assessed be estimated glomerular filtration rate) at two years after transplantation. | — |
Countries
United Kingdom
Outcome results
None listed