Open-label, randomised multicentre study of CAMPATH-1H versus basiliximab induction treatment and sirolimus versus tacrolimus maintenance treatment for the preservation of renal function in patients receiving kidney transplants

INTERVENTION:

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 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 30‐ Trade Name: Simulect Product Name: Basiliximab Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed

INN:

Basiliximab CAS Number: 152923‐56‐3 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 4‐ Trade Name: Rapamune Product Name: Sirolimus Pharmaceutical Form: Tablet INN or Proposed

INN:

Sirolimus CAS Number: 53123‐88‐9 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 1‐2 Trade Name: Prograf Product Name: Tacrolimus Pharmaceutical Form: Capsule, hard INN or Proposed

INN:

Tacrolimus CAS Number: 104987‐11‐3 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 0.5‐5

CONDITION:

Renal transplantation. ; MedDRA version: 14.1 Level: LLT Classification code 10023438 Term: Kidney transplant System Organ Class: 100000004865

PRIMARY OUTCOME:

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. 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. 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

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