Clinical Trial Search

Primary: Mean Belatacept Serum Concentrations Between Weeks 12 and 16 by Nominal Collection Time, Following 10mg/kg IV Belatacept - Pharmacokinetic Population — 8491.00; 242667…

Primary: Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation — 382.72; 147.82 ng*hr/mL

Primary: Pharmacokinetics of LCP-Tacro™ Tablets in the First 14 Days After Transplantation in Adult de Novo Kidney Recipients. — 78.57; 57.14 percentage of patients

Primary: Mean Cmax Pharmacokinetic Parameter- Part I — 66.3 ug/mL

Primary: Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. — 2; 4; 7; 0 Participants

Primary: Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus — 215.1; 206.6; 200.7; 197.6 ng*hr/mL

Primary: Dose-Normalized Area Under the Concentration-time Curve From Time 0 to 12 Hours (AUC0-12h) at Steady State — 51.73; 50.58 ng*hr/mL/mg — p=0.486

Primary: Evaluation of Steady State Tacrolimus Trough Levels (C24). — 7.00 ng/mL

Primary: Pharmacokinetics (Cmax and Cmin) of LCP-Tacro™ Compared to Prograf Early After Transplantations (Within the First 14 Days) in Adult de Novo Liver Transplant Recipients…

Primary: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550 — 183; 754; 1200 nanogram*hour per milliliter (ng*hr/mL)

Primary: Time to First Therapeutic Tacrolimus Trough Concentration From Initiation of Tacrolimus Extended Release Measured in Days — 4.5; 6; 13.5 days

Primary: Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review — 12.7; 26.3; 18.8; 16.7 percentage of participants

Primary: ANCOVA Model for Change in Nankivell GFR (mL/Min) at Month 6, Without Replacement of Missing Values (Full Analysis Set) — 47.65; 38.60 mL/min — p=0.0003

Primary: Evaluation of Steady State Tacrolimus Trough Levels (C24). — 6.72 ng/mL

Primary: Tacrolimus Bioavailability (F) — 0.224; 0.681 ratio of oral to IV — p=0.006

Primary: Biopsy Proven Acute Rejection (BPAR) — 2.3; 9.1; 10.7; 5.8 percentage of participants

Primary: Maximum Observed Serum Concentration (Cmax) of Belatacept — 151 micrograms per milliliter

Primary: Percentage of Participants With Efficacy Failure — 15.1; 14.0; 17.0 percentage of participants

Primary: Proportion of Patients Reaching Target Tacrolimus Levels (8-10 ng/mL) on Day 3 After Kidney Transplantation — 0.2; 0.14 proportion of participants — p=0.58

Primary: Maximum Observed Blood Concentration at Steady State (Cmax,ss) — 14.07 nanogram per milliliter (ng/mL)

Primary: The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies — 0.70; 0.90; 0.87; 0.79 Densitometry / Densitometry of…

Primary: Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus — 215.6; 184.0; 202.4; 187.9 ng*hr/mL

Primary: Renal Function Assessed by Calculated Glomerular Filtration Rate (cGFR) — 57.07; 51.73 mL/min/1.73m^2

Primary: Number of Participants With Biopsy-proven Acute Rejection — 21; 21 Participants

Primary: Percentage of Participants With Acute Rejection — 9.1 percentage of participants

Primary: GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen — 63.03; 68.59; 63.08 ml/min/1.73m² — p=< 0.0001

Primary: Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula) — 68.5; 69.2; 63.6; 68.3 mL/min per 1.73 m^2

Primary: Measured Glomerular Filtration Rate — 51.5; 47.8 mL/min/1.73m^2

Primary: Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6 — 1; 4; 1 participants

Primary: Participants With at Least One Occurrence of Safety Composite Endpoint After 6 Months by Treatment Group — 40; 30 participants — p=0.1043