Optimization of NULOJIX® (Belatacept) Usage As A Means of Avoiding Calcineurin Inhibitor (CNI) and Steroids in Renal Transplantation

This study has suspended participant recruitment.
(Due to safety and availability of campath (alemtuzumab))
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01436305
First received: September 13, 2011
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

Dialysis or kidney transplant are the two ways to treat kidney failure. Transplant recipients have to take anti-rejection medications to prevent their immune system (the body's natural defense system against illness) from rejecting their new kidney. Most patients who undergo a kidney transplant must take these anti-rejection medications for the rest of their lives. Taking standard anti-rejection medications for a long time can cause serious side effects, including kidney damage. There would be a benefit to finding new anti-rejection medications that work just as well, but don't damage the kidney. The purpose of this study is to find out if a new drug, NULOJIX® (belatacept), will minimize serious long term side effects seen with anti-rejection medications while still protecting the new kidney from damage. The researchers also want to learn more about the safety of this treatment and long term health of the transplanted kidney.

Due to safety and availability of campath (alemtuzumab), enrollment of new subjects in this trial is suspended, and subjects currently enrolled will be followed on a reduced follow-up schedule.


Condition Intervention Phase
Kidney Transplantation
Drug: Alemtuzumab induction
Drug: MMF
Biological: Basiliximab induction
Drug: Short-term (3 months) Tacrolimus
Drug: Tacrolimus
Biological: Belatacept
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: Optimization of NULOJIX® (Belatacept) Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation (CTOT-10)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • The incidence of all adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Enrollment to Year 5 ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: September 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tacrolimus maintenance Drug: Alemtuzumab induction Drug: MMF Drug: Tacrolimus
maintenance
Experimental: Belatacept maintenance Drug: Alemtuzumab induction Drug: MMF Biological: Belatacept
maintenance
Experimental: Basiliximab induction and Short-term Tacrolimus
Short term = 3 months
Drug: MMF Biological: Basiliximab induction Drug: Short-term (3 months) Tacrolimus
Short-term (3 months)
Biological: Belatacept
maintenance

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female, 18-65 years of age at the time of enrollment;
  • Ability to understand and provide written informed consent;
  • Candidate for primary renal allograft from either a living or deceased-donor;
  • No known contraindications to study therapy using NULOJIX® (belatacept);
  • Female participants of childbearing potential must have a negative pregnancy test upon study entry;
  • Female and male participants with reproductive potential must agree to use FDA approved methods of birth control during participation in the study and for 4 months following completion of the study;
  • Flow-based PRA within last 12 months (in absence of a sensitizing event) of < 30% as determined by each participating study center. If the subject experienced a sensitizing event after the PRA test date, then the PRA must be repeated and confirmed <30%;
  • Negative crossmatch or a PRA of 0% on historic and admission sera as determined by each participating study center.
  • A documented negative TB test within the 12 months prior to transplant. If documentation is not present at the time of transplantation, and the subject does not have any risk factors for TB, a TB-specific interferon gamma release assay (IGRA) may be performed.

Exclusion Criteria:

  • Need for multi-organ transplant;
  • Recipient of previous organ transplant;
  • EBV sero-negative (or unknown) recipients;
  • Active infection including hepatitis B, hepatitis C, or HIV;
  • Individuals who have required treatment with prednisone or other immunosuppressive drugs within 1 year prior to transplant;
  • Individuals undergoing transplant using organs from ECD or DCD donors;
  • HLA identical living donors;
  • Individuals at significant risk of early recurrence of the primary renal disease including FSGS and MPGN type 2 or any other disease that in the opinion of the investigator is at increased likelihood of recurrence and which may result in rapid decline in renal function;
  • Individuals previously treated with NULOJIX® (belatacept);
  • Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements;
  • Use of investigational drugs within 4 weeks of enrollment;
  • Known hypersensitivity to mycophenolate mofetil (MMF)or any of the drug's components;
  • Administration of live attenuated vaccine(s) within 8 weeks of enrollment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436305

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Investigators
Study Chair: Ken Newell, MD, PhD Emory University
Principal Investigator: Christian Larsen, MD, DPhil Emory University
  More Information

No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01436305     History of Changes
Other Study ID Numbers: DAIT CTOT-10
Study First Received: September 13, 2011
Last Updated: November 1, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Tacrolimus
Campath 1G
Basiliximab
Abatacept
Alemtuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014