CamTac Trial:Campath-Tacrolimus vs IL2R MoAb/Tacrolimus/MMF in Renal Transplantation

NCT00246129 | Completed Phase 4 Results DMC

• 2 other identifiers: SMHREN05012005-002856-17
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

The advent of new, potent immunosuppressive (anti-rejection) drugs over the past ten years has substantially reduced the risk of rejection after kidney transplantation, has allowed the development of immuno-suppressive regimens that do not use long-term steroids (steroid avoidance), and has improved transplant success rates both in the short and medium term. The main new agents used in these modern regimens are the calcineurin inhibitor (CNI) tacrolimus; the anti-proliferative agent mycophenolate; and induction agents which are used to provide effective early suppression of the rejection process; these include monoclonal antibodies (MoAb) such as IL-2 receptor blocking antibodies (IL-2R MoAb: basiliximab and daclizumab) and the anti-CD52 antibody Campath-1H (alemtuzumab). Although almost all modern immunosuppressive regimens involve one or more of these agents, it is not known which is the safest and most effective combination. This randomised controlled trial compares two steroid sparing regimens which have been used with very good short and medium term results at St Mary's Hospital Renal and Transplant Unit over the last 5 years. The primary hypothesis is that the alemtuzumab/tacrolimus regimen is as effective and safe as the IL-2R MoAb/tacrolimus/mycophenolate regimen.

Conditions

Kidney Transplantation; Kidney Diseases; Kidney Failure

Keywords

Kidney Transplantation; Kidney Disease; Kidney Failure; Graft Rejection

Outcome Measures

Primary Outcomes (1)

• One Year Survival With a Functioning Graft

  One year survival with a functioning graft, defined as transplant recipient remaining alive and dialysis-independent. the functioning graft is a graft still functioning at the time of analysis. Graft function was estimated using the Modification of Diet in Renal Disease four-variable formula and comparison of graft function between arms undertaken with Student'st test.

  1 year

Secondary Outcomes (8)

• Occurrence of Rejection Episodes

  1 year

• Occurrence of Significant Episodes of Infection

  1 year

• Initial Length of Stay in Hospital

  1 year

• Presence in the Blood of Cells Which Might Trigger Rejection in, or Promote Tolerance to the Graft

  3 years

• Early Development of Scarring in the Grafts

  1 year

Study Arms (2)

Campath-Tacrolimus

ACTIVE COMPARATOR

Campath induction with 7-day short-course steroids followed by tacrolimus monotherapy

Drug: Campath

Daclizumab-Tacrolimus-Mycophenolate

EXPERIMENTAL

Daclizumab induction with 7-day short-course steroids followed by Tacrolimus and Mycophenolate mofetil therapy

Drug: Daclizumab

Interventions

Campath DRUG

Monoclonal antibody induction therapy

Also known as: Alemtuzumab

Campath-Tacrolimus

Daclizumab DRUG

Monoclonal antibody induction therapy

Also known as: Zinbryta

Daclizumab-Tacrolimus-Mycophenolate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kidney transplant recipients under the care of the West London Renal and Transplant Centre

You may not qualify if:

• Patients who are unable to give written informed consent
• Simultaneous kidney/pancreas transplant recipients
• Non-heart beating deceased donor transplant recipients
• Patients who would not be offered Campath-1H induction under our current protocol (patients with previous malignancy or with previous exposure to cytotoxic or antiproliferative agents)

Sponsors & Collaborators

• EMagnusson: lead

Study Sites (1)

West London Renal and Transplant Centre, 4th Floor Ham House, Hammersmith Hospital

London, W12 OHS, United Kingdom

Location

Related Publications (4)

• Loucaidou M, McLean AG, Cairns TD, Griffith M, Hakim N, Palmer A, Papalois V, Van Tromp J, Loucaides C, Welsh KI, Taube D. Five-year results of kidney transplantation under tacrolimus-based regimes: the persisting significance of vascular rejection. Transplantation. 2003 Oct 15;76(7):1120-3. doi: 10.1097/01.TP.0000076474.76480.A4.

  PMID: 14557763 BACKGROUND

• Borrows R, Loucaidou M, Van Tromp J, Cairns T, Griffith M, Hakim N, McLean A, Palmer A, Papalois V, Taube D. Steroid sparing with tacrolimus and mycophenolate mofetil in renal transplantation. Am J Transplant. 2004 Nov;4(11):1845-51. doi: 10.1111/j.1600-6143.2004.00583.x.

  PMID: 15476485 BACKGROUND

• Borrows R, Loucaidou M, Van Tromp J, Singh S, Cairns T, Griffith M, Hakim N, McLean A, Palmer A, Papalois V, Taube D. Steroid sparing in renal transplantation with tacrolimus and mycophenolate mofetil: three-year results. Transplant Proc. 2005 May;37(4):1792-4. doi: 10.1016/j.transproceed.2005.03.150.

  PMID: 15919468 BACKGROUND

• Chan K, Taube D, Roufosse C, Cook T, Brookes P, Goodall D, Galliford J, Cairns T, Dorling A, Duncan N, Hakim N, Palmer A, Papalois V, Warrens AN, Willicombe M, McLean AG. Kidney transplantation with minimized maintenance: alemtuzumab induction with tacrolimus monotherapy--an open label, randomized trial. Transplantation. 2011 Oct 15;92(7):774-80. doi: 10.1097/TP.0b013e31822ca7ca.

  PMID: 21836540 RESULT

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency

Interventions

Alemtuzumab; Daclizumab

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Our trial was conservatively powered to detect a large difference in survival with a functioning graft at 1 year, so we are not able to exclude the possibility of small differences, the single-centre nature of the study may limit it's applicability.

Results Point of Contact

• Title: Dr Adam McLean
• Organization: imperial College Kidney & Transplant Centre

adam.mclean@imperial.nhs.uk

+44 (0) 208 383 5164

Study Officials

• Adam G McLean, FRCP, DPhil

  Hammersmith Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

• David H Taube, MBBCh, FRCP

  Hammersmith Hospital NHS Trust

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: RIO

Study Record Dates

• First Submitted: October 28, 2005
• First Posted: October 31, 2005
• Study Start: October 1, 2005
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 29, 2021
• Results First Posted: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)