NCT02878616

Study in End-stage Renal Disease Patients Awaiting Kidney Transplant to Investigate the Potential Effect of IVIG Treatment on the Pharmacokinetics and Pharmacodynamics of LFG316

Open-label, Parallel-group, Drug-drug Interaction Study in End-stage Renal Disease Patients Awaiting Kidney Transplant to Investigate the Potential Effect of IVIG Treatment on the Pharmacokinetics and Pharmacodynamics of LFG316

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Investigate whether concomitant treatment with intravenous immunoglobulin (IVIG) can alter the pharmacokinetics and pharmacodynamics of LFG316 to an extent which would necessitate dose adaptation for LFG316 in pre-sensitized end-stage renal disease patients awaiting kidney transplantation

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	LFG316	LFG316 single dose
DRUG	IVIG	IVIG single dose

Timeline

• Start date: 2016-08-26
• Primary completion: 2017-07-19
• Completion: 2017-07-19
• First posted: 2016-08-25
• Last updated: 2020-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study