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