Phase 2
N=18
A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection
Graft Rejection
Bottom Line
View on ClinicalTrials.gov: NCT01147302 ↗Enrolled (actual)
18
Serious AEs
22.2%
Results posted
Jul 2015
Primary outcome: Primary: Change From Baseline in Histopathology Endpoints — -45.0; -36.1; -6.0; 12.6 scores on a scale — p=0.6498
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Biological); C1 Esterase Inhibitor (Human) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Histopathology Endpoints |
-45.0; -36.1; -6.0; 12.6; 6.7; 2.7 | 0.6498 |
| SECONDARY Number of Participants With Resolution of The Qualifying Episode of Antibody-Mediated Rejection (AMR) |
6; 7; 3; 0; 4; 7 | — |
| SECONDARY Change From Baseline in Serum Creatinine |
-0.2; -0.1; -0.1; -0.1 | 0.7591 |
| SECONDARY Change From Baseline in Creatinine Clearance |
11.4; 12.9; 3.4; 8.1 | 0.9046 |
| SECONDARY Number of Plasmapheresis Sessions |
7.4; 9.0; 10.4; 10.7 | 0.4558 |
| SECONDARY Number of Participants Who Required Salvage Splenectomy |
0; 0 | — |
| SECONDARY Number of Deaths |
0; 0 | — |
| SECONDARY Number of Participants With Allograft Failure |
0; 0 | — |
| SECONDARY Serum Concentrations of C1 Inhibitor (C1 INH) Antigen |
0.149; 0.115; 0.131; 0.129; 0.014; 0.081 | — |
| SECONDARY Serum Concentrations of C1 INH Functional Activity |
1.24; 0.777; 1.02; 0.961; 0.147; 0.884 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of C1 INH |
43.2; 0.55; 4.07; 3.88 | — |
| SECONDARY Area Under The Concentration-Time Curve (AUC) of C1 INH Antigen |
0.590; 2.51; 2.24; 8.64 | — |
| SECONDARY Area Under The Concentration-Time Curve (AUC) of C1 INH Functional Activity |
9.82; 34.1; 30.8; 113 | — |
Summary
The purpose of this research study is to evaluate the safety, effect, and pharmacology of C1 Esterase Inhibitor (human) in kidney transplant patients with acute Antibody-Mediated Rejection (AMR).
Eligibility Criteria
Inclusion Criteria include:
- ≥18 years of age.
- Weigh ≥50 kg.
- Donor specific antibody identified.
Exclusion Criteria include:
- Any surgical or medical condition that could interfere with the administration of study drug or interpretation of study results.
- History of allergic reaction to C1 Esterase Inhibitor or other blood products.
- Participation in the active dosing phase of any other investigational drug study within 30 days prior to dosing with study drug.
- Pregnancy or lactation.
- Receipt of any experimental agents for AMR within 1 month prior to the first dose of study drug.
- Any infection that causes hemodynamic compromise.
- History of bleeding or clotting abnormality.
Data sourced from ClinicalTrials.gov (NCT01147302). 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.