Phase 1 N=16 Randomized Treatment

Eculizumab Therapy for Chronic Complement-Mediated Injury in Kidney Transplantation

Kidney; Complications, Allograft

Bottom Line

View on ClinicalTrials.gov: NCT01327573 ↗

Enrolled (actual)

Serious AEs

46.7%

Results posted

Aug 2019

Primary outcome: Primary: Baseline eGFR (Estimated Glomerular Filtration Rate) — 30.04; 30.04 mL/min/1.73 m2

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: eculizumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sanjay Kulkarni
Primary completion: Feb 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Baseline eGFR (Estimated Glomerular Filtration Rate)	30.04; 30.04	—
PRIMARY Estimated Glomerular Filtration Rate (eGFR) at Months 2,3,4,5,6	29.34; 31.34; 29.56; 30.68; 29.78; 30.02	0.09
PRIMARY Group Difference Percentage Change in 6-month Estimated Glomerular Filtration Rate (eGFR)	6.66; 3.73; 0.80; -2.13; -5.06	—

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.

Eligibility Criteria

Inclusion Criteria

Kidney transplant recipients greater than 6 months from the date of transplant
Must be on standard immunosuppression: tacrolimus, mycophenolate mofetil, prednisone and have stable tacrolimus trough levels over past 3 months
Deteriorating renal function, as defined by 20% reduction in GFR (MDRD calculation)
Presence of DSA, as defined as MFI > 1100
Renal biopsy demonstrating no diffuse, irreversible end-stage organ injury (i.e. stage IV Fibrosis)
Renal biopsy demonstrating C4d deposition (stratum 1) or no C4d deposition (stratum 2)

Exclusion Criteria

History of CMV, BK, HSV or other viral infections
History of chronic, recurrent bacterial infections
Evidence of tubulitis on renal biopsy or other morphological features of acute cellular rejection or acute humoral rejection
Renal biopsy demonstrating diffuse, irreversible end-stage organ injury
Absolute GFR < 25 (MDRD calculation)
Inability to provide informed consent
History of poor vascular access
Refusal to use double barrier contraception during study participation
Patients actively enrolled in other clinical trials

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01327573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.