CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
eculizumabdrug
Likely dose
eculizumab 600mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01327573
NCT01327573Phase 1Completed
CompareCT.gov

Eculizumab Therapy for Chronic Complement-Mediated Injury in Kidney Transplantation: A Randomized, Open-Label, Pilot Intervention Trial

Sanjay Kulkarni·interventional·Posted Apr 1, 2011·Updated Aug 12, 2019

In Brief

A Phase 1 clinical trial evaluating eculizumab for Kidney; Complications, Allograft. Completed, enrolled 16 participants across 1 site.

Detailed Summary

This study is designed to assess the effectiveness of eculizumab in recipients of kidney transplantation with donor-specific antibodies (DSA) and worsening kidney function and to assess if eculizumab improves endothelial cell injury in the kidney. The investigators hypothesize that complement inhibition with eculizumab will reduce allograft injury, resulting from less complement-mediated injury of endothelial cells and less endothelial cell activation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney; Complications, Allograft
CountriesUnited States
CollaboratorsAlexion Pharmaceuticals, Inc.

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 1, 2011
Enrollment StartMar 1, 2011
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 15.3 years ago

Interventions

eculizumabdrug

* Eculizumab Induction 600mg IV every 7 days for 4 doses * Eculizumab 900mg IV 7 days later * Eculizumab Maintenance 900mg IV every 14 days for total of 26 weeks