NCT03470961

Observational Study to Evaluate the Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients

Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients: Single-centre, Prospective, Observational Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Tianjin First Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A single-centre, prospective, observational study to evaluate the safety and efficacy of Polyclonal Antibodies in simultaneous Pancreas Kidney Transplant recipients.

Detailed description

Polyclonal antibody mainly contains Antit-Tlymphocyte globulins(Grafalon) and Anti-thymocyte globulins(ATG). To investigate the efficacy and safety of polyclonal antibodies induction regimen using Grafalon compared with ATG in de novo simultaneous pancreas kidney transplant recipients. The primary analysis of this study is to demonstrate the non-inferiority of the two regimens with regard to efficacy, defined as failure rate. The secondary objective of the study is the assessment of safety and further efficacy parameters in terms of incidence of acute rejections, graft/patient survival, DGF(delayed graft function), pancreas function and renal function

Conditions

• CKD (Chronic Kidney Disease) Stage 5T
• Diabetes Mellitus
• Simultaneous Pancreas Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Anti-Tlymphocyte Globulins	Induction therapy regimen in simultaneous pancreas kidney transplantation
DRUG	Anti-Thymocyte Globulins	Induction therapy regimen in simultaneous pancreas kidney transplantation

Timeline

• Start date: 2018-03-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2018-03-20
• Last updated: 2018-03-20

Locations

1 site across 1 country: China