Low Dose Sirolimus or CsA-Based Maintenance Immunosuppression After Induction With Campath-1 in Kidney Transplantation

This study has been completed.
Sponsor:
Information provided by:
Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier:
NCT00309270
First received: March 30, 2006
Last updated: May 18, 2006
Last verified: March 2006
  Purpose

During the past 15 years, however, the superior immunosuppressive efficacy of CsA and the well-known toxicity of long-term steroid therapy have prompted trials of steroid withdrawal from renal allograft recipients at various intervals after transplantation. Steroid withdrawal or avoidance must be balanced against the associated risk of precipitating acute allograft rejection. Moreover, with the current immunosuppressive regimens, by 10 years approximately 50% of grafts will have been lost due mainly to chronic rejection or the side-effects of immunosuppressive therapy. Thus, the quest for therapies that might induce specific immune tolerance – ideally via short-term interventions that would target only the pathogenic immune response and leave the protective host immune response unimpaired – has provided a “holy grail” for transplant immunologists.

The humanized IgG monoclonal antibody Campath-1H has been hypothesized to provide enough immunosuppression that would allow maintenance therapy with low-dose CsA, and possibly reprogramming the immune system so to encourage tolerance processes. Despite Campath-1H immunosuppressive regimens have been claimed to induce a condition of “almost tolerance”, this has not been proved nor evidence of development of persistent regulatory immune responses long-term post transplant has been provided. Thus, characterizing phenotypically and functionally distinct subsets of T-regulatory cells possibly generated selectively in non-rejecting transplant recipients in Campath-1H-based immunosuppressive regimens may help to find new noninvasive markers of immune system activation to tailor immunosuppressive protocols.

The primary aim of the study is to compare the effect of Campath-1H, low dose sirolimus versus Campath-1H, low dose CsA, both in addition to low dose MMF on phenotypic and functional profiles of peripheral blood mononuclear cells (PBMCs) in kidney transplant recipients in a steroid-free regimen.


Condition Intervention Phase
Kidney Transplant
Drug: Campath-1H
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Study to Compare the Effect of Campath-1,Low Dose Sirolimus Versus Campath-1H, Low Dose CsA Both in Addition to Low Dose Mycophenolate Mofetil on Phenotypic and Functional Profiles of PBMCs in Kidney Transplant Recipients in a Steroid-Free Regimen

Resource links provided by NLM:


Further study details as provided by Mario Negri Institute for Pharmacological Research:

Primary Outcome Measures:
  • Time course of immunophenotyping and lymphocyte function assays in the two groups of kidney transplant recipients randomized to low-dose sirolimus or CsA- based maintenance immunosuppression after Campath-1H induction therapy
  • Graft function and survival
  • Safety of induction therapy with Campath-1H and low-dose maintenance immunosuppressive regimen

Estimated Enrollment: 21
Study Start Date: February 2003
Estimated Study Completion Date: April 2010
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible kidney transplant according to standard criteria
  • Recipient of first kidney transplant
  • Cadaver or living-related donor
  • Written informed consent

Exclusion Criteria:

  • Panel reactive antibodies titer >50%
  • HLA identical
  • High risk of recurrence of renal disease (FSGS, vasculitis, membranous nephropathy)
  • Primary and secondary hyperlipidemia
  • Platelet count <150000/microliter
  • Specific contraindication to the study drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309270

Locations
Italy
Hospital "Ospedali Riuniti" of Bergamo
Bergamo, Italy, 24128
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Investigators
Principal Investigator: Norberto Perico, MD Mario Negri Institute for Pharmacological Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00309270     History of Changes
Other Study ID Numbers: CAMPATH
Study First Received: March 30, 2006
Last Updated: May 18, 2006
Health Authority: Italy: Ministry of Health

Keywords provided by Mario Negri Institute for Pharmacological Research:
Campath-1H, low-dose immunosuppression, T regulatives cells

Additional relevant MeSH terms:
Alemtuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014