Study to Improve Renal Function After Kidney Transplantation

Status Active, not recruiting

Clinical Trial Summary

The objective of the study is to evaluate the safety and activity of a investigational drug in improving renal function in patients who have undergone renal transplantation and have signs and symptoms of significant renal injury and are at risk for dialysis.

Clinical Trial Description

Delayed graft function (DGF) is generally defined as the need for dialysis during the first 7 days after transplantation although the definition can also include failure to improve preexisting renal function. DGF is an important problem in renal allograft transplantation that affects approximately 25% of transplanted cadaveric kidneys. It has generally been observed that delayed graft function has been associated with reduced graft survival. In addition to an association of DGF with graft loss, DGF imposes an economic burden due to prolonged hospitalization and dialysis. The strongest association with occurrence of DGF is ischemia around the time of transplantation. Aside from approaches to minimize ischemia time and use of antibody induction, there are no good specific therapeutic options to prevent or treat delayed graft function. This study is designed to evaluate the safety and activity of an investigational drug in improving renal function in patients who have undergone renal transplantation and have signs and symptoms of significant renal injury and are at risk for dialysis. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Delayed Graft Function

Clinical Trial Details

NCT number	NCT01286727
Study type	Interventional
Source	Angion Biomedica Corp
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	February 2010
Completion date	February 2016

View Details

See also
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Completed	`NCT01794663` - Placebo-Controlled Study to Evaluate the Safety and Efficacy of OPN-305 in Preventing Delayed Renal Graft Function	Phase 2
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Active, not recruiting	`NCT02568696` - Intra-graft Coagulation Events in Clinical Renal Transplantation and Delayed Graft Function
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