Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Precision Medicine Offers Belatacept Monotherapy (PROBE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02939365
Recruitment Status : Not yet recruiting
First Posted : October 20, 2016
Last Update Posted : October 20, 2016
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Flavio Vincenti, University of California, San Francisco

Brief Summary:
The purpose of this study is to determine the safety and feasibility of converting patients to Belatacept monotherapy (receiving just one immunosuppression drug), and to see what percentage of those patients can be safely converted to once every 8 week administration of Belatacept. Belatacept has been approved by the Food and Drug Administration (FDA) for kidney transplant recipients.

Condition or disease Intervention/treatment Phase
Transplantation Drug: Belatacept Phase 4

Detailed Description:

Patients on belatacept who fulfill the entry criteria will be screened to determine if they have a quiescent molecular immunologic profile with kSORT and uCRM. Patients who screen negative on all 2 tests will undergo stepwise withdrawal first of steroids then of MMF or mTor inhibitors. Prior to each withdrawal the 2 screening molecular tests will be performed and advancement to the next withdrawal phase will be performed if both are negative. Patients who are maintained on belatacept monotherapy with quiescent kSORT and uCRM and elevated kSPOT will be transitioned to q 8 weeks belatacept administration.

Forty patients who are previously enrolled in belatacept based regimens with a minimum of 7 years of follow up at 4 transplant centers and who are maintained on belatacept, an antiproliferative ± steroids will be approached for enrollment.

Drug withdrawal of steroids (in patients on steroids) and of antiproliferatives (MPAs or mTor inhibitors) will follow the design shown in the Study Schema. Patients who continue to be stable for 3 months on belatacept monotherapy will be converted from q 4 weeks to q 8 weeks belatacept administrations.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Precision Medicine Offers Belatacept Monotherapy (PROBE)
Study Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Belatacept

Arm Intervention/treatment
Experimental: Belatacept patients

Forty patients who are previously enrolled in belatacept based regimens with a minimum of 7 years of follow up at 4 transplant centers and who are maintained on belatacept, an antiproliferative ± steroids will be approached for enrollment.

Drug withdrawal of steroids (in patients on steroids) and of antiproliferatives (MPAs or mTor inhibitors). Patients who continue to be stable for 3 months on belatacept monotherapy will be converted from q 4 weeks to q 8 weeks belatacept administrations.

Drug: Belatacept
The transition to belatacept monotherapy and possibly to q 8 weeks administration can be safely done by applying personalized (i.e. precision) medicine. This includes phenotypic analysis of lymphocyte subsets, a quiescent molecular profiling of blood and urine prior to drug withdrawal and immune monitoring with KSORT after stepwise withdrawal of steroids and antiproliferatives. Furthermore, trough PK of belatacept will be measured for conversion to q 8 week therapy for discovering research purposes.
Other Name: Nulojix®




Primary Outcome Measures :
  1. Percent patients converted to belatacept [ Time Frame: 12 months ]
    To determine the percent of patients that can be safely converted to belatacept monotherapy

  2. Percent patients safely converted to q8 week administration [ Time Frame: 12 months ]
    2. To determine the percent of patients on belatacept monotherapy that can be safely converted to 8 week administration of belatacept



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable renal function with a GFR ≥ 35 ml/min
  • No history of acute rejection
  • A spot urine protein creatinine ratio of 0.5 or less
  • No DSA

Entry: Biomarker criteria

  • Blood kSORT and urine CRM tests that are quiescent at entry and following each drug withdrawal.
  • A third biomarker KSPOT will be used to assess if any patients has achieved tolerance.

Eligibility for 8 week Belatacept Administration

  • Trough levels of belatacept at 4 weeks of greater than 2 µg/ml
  • Trough levels of belatacept at 8 weeks of equal or greater than 1 µg/ml

Exclusion Criteria:

  • Patients with < eGFR (35 ml/min)
  • History of rejection
  • Protein/creatinine rate >0.5
  • Presence of DSA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939365


Contacts
Layout table for location contacts
Contact: Flavio Vincenti, MD 415-353-1322 flavio.vincenti@ucsf.edu
Contact: Erica Tavares 415-353-8380 Erica.Tavares@ucsf.edu

Sponsors and Collaborators
University of California, San Francisco
Bristol-Myers Squibb

Layout table for additonal information
Responsible Party: Flavio Vincenti, Professor of Clinical Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02939365     History of Changes
Other Study ID Numbers: IM103-382
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents