Trial Outcomes & Findings for Mechanisms of Belatacept Effect on Alloimmunity and Antiviral Response After Kidney Transplantation (BMS IM 103-309) (NCT NCT01953120)

NCT ID: NCT01953120

Last Updated: 2022-12-13

Results Overview

To analyze the effect of switching from CNI to belatacept in patients with evidence of CNI toxicity on the development and maintenance of immune memory in response to both alloantigen and viral antigens commonly encountered after transplant, and to assess the safety and efficacy of conversion to belatacept as maintenance immunosuppression in combination with prednisone and mycophenolate mofetil.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Month 6

Results posted on

2022-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	Belatacept Survival and rejection in patients switched to belatacept. Belatacept: Subjects will receive intravenous belatacept at 5mg/kg every other week starting from day 1 and continuing with weeks 2, 4, 6, and 8, and then monthly at months 3, 4, 5, and 6. At month 6 patients may elect to continue for an additional six-month period of belatacept administration.
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mechanisms of Belatacept Effect on Alloimmunity and Antiviral Response After Kidney Transplantation (BMS IM 103-309)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Belatacept n=19 Participants Survival and rejection in patients switched to belatacept. Belatacept: Subjects will receive intravenous belatacept at 5mg/kg every other week starting from day 1 and continuing with weeks 2, 4, 6, and 8, and then monthly at months 3, 4, 5, and 6. At month 6 patients may elect to continue for an additional six-month period of belatacept administration.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Induction, Anti-thymocyte globulin (ATG)	6 Participants n=5 Participants
Deceased Donor	8 Participants n=5 Participants
Cytomegalovirus (CMV) Seropositive	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 6

Population: Clinical outcomes measured included CMV viremia, PTLD, development of donor specific antibodies, acute rejection, and death. Laboratory based measurements included immune phenotype, alloimmune response as measured by intracellular cytokine stimulation (ICS), and antiviral immune response to CMV and EBV as measured by ICS.

Outcome measures

Outcome measures
Measure	Belatacept n=19 Participants Survival and rejection in patients switched to belatacept. Belatacept: Subjects will receive intravenous belatacept at 5mg/kg every other week starting from day 1 and continuing with weeks 2, 4, 6, and 8, and then monthly at months 3, 4, 5, and 6. At month 6 patients may elect to continue for an additional six-month period of belatacept administration.
Antibody and T Cell-mediated Immune Response CMV Viremia	17 participants
Antibody and T Cell-mediated Immune Response PTLD	0 participants
Antibody and T Cell-mediated Immune Response Development of Donor Specific Antibodies	0 participants
Antibody and T Cell-mediated Immune Response Acute Rejection	1 participants
Antibody and T Cell-mediated Immune Response Death	0 participants

SECONDARY outcome

Timeframe: Months 1, 3, and 12 if applicable as the secondary measures continue belatacept treatment

Incidence of de novo DSA detected at one or more time points during the period of study

Outcome measures

Outcome measures
Measure	Belatacept n=19 Participants Survival and rejection in patients switched to belatacept. Belatacept: Subjects will receive intravenous belatacept at 5mg/kg every other week starting from day 1 and continuing with weeks 2, 4, 6, and 8, and then monthly at months 3, 4, 5, and 6. At month 6 patients may elect to continue for an additional six-month period of belatacept administration.
Post-transplant de Novo Donor Specific Antibody (DSA)	0 Participants

Adverse Events

Belatacept

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Suphamai Bunnapradist

UCLA

Phone: 3107948516

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place