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. 2017 Jan 11;2017(1):CD004759. doi: 10.1002/14651858.CD004759.pub2

NCT01154387.

Trial name or title Evaluating safety and efficacy of TOL101 induction versus anti‐thymocyte globulin to prevent kidney transplant rejection
Methods Randomised, open‐label, parallel assignment (Phase 1 and Phase 2)
Participants 85 participants, age 18‐60, first kidney transplant recipients
Interventions ATG versus TOL101 dose A versus TOL101 dose B
Outcomes Primary: safety and tolerability of ascending doses of TOL101 and effectiveness of TOL101 to target and down regulate T cells at 6 months
Secondary: effects of ascending doses of TOL101 on CD3+ T lymphocyte numbers and other immune cell subsets at 14 days and 6 months, pharmacokinetic profile of TOL101 and exposure‐response relationship over time at 14 days, biopsy‐proven acute organ rejection at 6 months, graft survival at 6 months, patient survival at 6 months, kidney function by measured GFR at 6 months and urine protein to creatinine ration at 3 and 6 months, DGF at 7 days, immunogenicity of TOL101 by measurement of anti‐TOL101 antibodies at 14 and 28 days, presence of DSA at 3 months and 6 months
Starting date July 2010
Contact information Tolera Therapeutics Inc (Stuart Flechner MD, The Cleveland Clinic)
Notes Estimated study completion date was June 2013; recruitment status was active; not recruiting; study details last verified in June 2013