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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02939365
Other study ID # IM103-382
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date February 2019
Est. completion date December 2022

Study information

Verified date December 2022
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2022
Est. primary completion date February 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco Bristol-Myers Squibb

Outcome

Type Measure Description Time frame Safety issue
Primary Percent patients converted to belatacept To determine the percent of patients that can be safely converted to belatacept monotherapy 12 months
Primary Percent patients safely converted to q8 week administration 2. To determine the percent of patients on belatacept monotherapy that can be safely converted to 8 week administration of belatacept 12 months
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