Precision Medicine Offers Belatacept Monotherapy

NCT02939365 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: IM103-382
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Transplantation

Outcome Measures

Primary Outcomes (2)

• Percent patients converted to belatacept

  To determine the percent of patients that can be safely converted to belatacept monotherapy

  12 months

• 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

Study Arms (1)

Belatacept patients

EXPERIMENTAL

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

Interventions

Belatacept DRUG

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.

Also known as: Nulojix®

Belatacept patients

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Bristol-Myers Squibb: collaborator

MeSH Terms

Interventions

Abatacept

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Officials

• Flavio Vincenti, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 20, 2016
• Study Start: February 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: December 1, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share