A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01820572
• Date of registration: 14/03/2013
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
• Scientific title: Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based Immunosuppression
• Date of first enrolment: March 27, 2013
• Target sample size: 449
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01820572
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Austria, Colombia, France, Germany, Greece, Netherlands, Norway, Sweden, Switzerland, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Men and women, ages 18-75 inclusive

- Adult recipients of a renal allograft from a living donor or a deceased donor between
6-60 months prior to enrollment

- Receiving a stable (=1 month) regimen of Calcineurin inhibitor (CNI) [Cyclosporine A
(CsA) or Tacrolimus (TAC)] with Mycophenolate mofetil (MMF) or Enteric Coated
Mycophenolate Sodium (EC-MPS)/Mycophenolic acid (MPA), and corticosteroids

- Stable renal function for 12 weeks prior to enrollment without new onset proteinuria

- Calculated glomerular filtration rate (cGFR) =30 and =75 mL/min/1.73 m2 [Modification
of Diet in Renal Disease study (MDRD) 4-formula]

Exclusion Criteria:

- Recipients with Epstein-Barr virus (EBV) serostatus negative or unknown

- History of acute rejection (AR) within 3 months prior to enrollment

- History of antibody mediated rejection

- Positive T-cell lymphocytotoxic cross match

- Proteinuria >1 g/day or >0.5 g/day if diabetic



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Kidney Transplantation

Intervention(s)

Drug: Belatacept

Drug: Tacrolimus

Drug: Cyclosporine

Primary Outcome(s)

Proportion of subjects who survive with a functional graft at 24 months post randomization [Time Frame: 24 months]

Secondary Outcome(s)

Hypertension - Mean change in systolic and diastolic blood pressure from baseline to 12 and 24 months post-randomization, and intensity of anti-hypertensive treatment regimens from baseline to 12 and 24 months [Time Frame: Baseline (Day 1) to 12 and 24 months]

Symptom occurrence and symptom distress measured with the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59R (MTSOSDS-R 59) at baseline, Week 6, and 3, 6, and 12 months post-randomization [Time Frame: Baseline (Day 1), Week 6 and 3, 6 and 12 months]

Safety and tolerability of a Belatacept-based immunosuppressive regimen-Proportions and incidence rates of all AEs, AEs of special interest, Clinically significant changes in vital signs, Laboratory test abnormalities, Clinically tolerability of the drug [Time Frame: 12 and 24 Months]

Renal Function - Slopes of cGFR and 1/serum creatinine respectively from baseline as well as Month 3 to 12 and 24 months post-randomization [Time Frame: Baseline (Day 1), 3 to 12 and 24 months]

Severity of AR post-randomization [Time Frame: 12 and 24 months]

Incidence of acute rejection (AR) post-randomization [Time Frame: 12 and 24 months]

Renal Function - Mean change in cGFR (MDRD) from baseline to 12 and 24 months post-randomization (% and absolute) [Time Frame: Baseline (Day 1) to 12 and 24 months]

Renal Function - Proportion of subjects with >5% and >10% improvement over baseline in cGFR at 12 and 24 months post-randomization [Time Frame: 12 and 24 months]

Patient and Graft Survival - Proportion of subjects who survive with a functional graft at 12 months post-randomization [Time Frame: 12 month]

Donor Specific Antibodies (DSA) - Proportion of donor specific antibodies (DSA) at 12 and 24 months post-randomization [Time Frame: 12 and 24 Months]

Renal Function - Urine protein/creatinine ratio (UPCR) at baseline, 3, 6, 12 and 24 months post-randomization [Time Frame: Baseline (Day 1), 3, 6, 12 and 24 months]

Secondary ID(s)

2012-001314-42

IM103-116

Source(s) of Monetary Support

Please refer to primary and secondary sponsors