Efficacy and Safety of Alemtuzumab for prevention of graft rejection and preservation of renal function in patients receiving Kidney Transplant

Phase 3

Active, not recruiting

• Conditions: End stage kidney failure; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12610000837022
• Lead Sponsor: ational University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Aged 18 – 65 years
- Renal failure with no previous renal transplantation
- Cadaveric or live donor kidney transplant recipient
- Written informed consent given

Exclusion Criteria

- Pregnant or nursing or woman of child bearing potential unwilling/unable to practice an acceptable form of birth control
- Major systemic or other illness that would, in the opinion of the investigator, interfere with the patient’s ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of study results
- Multi-organ transplant recipient
- Prior renal transplants
- Previous treatment with alemtuzumab
- Patient requiring anti-lymphocyte preparations/interleukin receptor antibody preparations for induction therapy
- Patient requiring cyclosporine, mycophenolic acid analogues or Mammalian Target of Rapamycin (mTOR) inhibitors as initial therapy
- Use of other investigational agents within 6 weeks prior to transplantation
- Active systemic infection
- Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen or anti-hepatitis C antibody positive (if Hepatitis C Virus Polymerase Chain Reaction (HCV PCR) unavailable) or Hepatitis C Virus Polymerase Chain Reaction (HCV PCR) positive
- Positive T lymphocyte cytotoxicity cross-match between recipient serum and donor cells
- Autoimmune hemolytic anemia
- Past history of anaphylaxis following exposure to humanised monoclonal antibodies
- Panel Reactive Antibodies (PRA) equal or greater than 50%
- Inability to undergo transplant biopsy, including patient who will require anticoagulation
- Cold ischemia time greater than 24 hours
- Patient whose graft function or perfusion cannot be demonstrated within 5 hours post-anastomosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of chronic lesions of Interstitial Fibrosis /Tubular Atrophy and calcineurin inhibitor nephrotoxicity on protocol biopsy[For both groups, followup will be from time of transplant surgery, unitl 36 months post transplant surgery.]