Trials / Terminated
TerminatedNCT02547220
A Multicenter Study to Evaluate the Efficacy and Safety of Cinryze® for the Treatment of Acute Antibody-mediated Rejection in Participants With Kidney Transplant
A Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Cinryze® (C1 Esterase Inhibitor [Human]) for the Treatment of Acute Antibody-mediated Rejection in Kidney Transplant Patients
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of the study is to evaluate the efficacy of CINRYZE administered with plasmapheresis, plasma exchange, or immune adsorption treatments and sucrose-free immunoglobulin (IVIg) for the treatment of acute antibody-mediated rejection (AMR) of renal allograft in kidney transplant recipients as measured by the proportion of participants with new or worsening transplant glomerulopathy (TG) at 6 months after treatment initiation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Cinryze® | Participants will receive 5000 Units of CINRYZE (50 millilitre \[mL\] of CINRYZE/ 50 mL of normal saline) on Day 1 and 2500 Units of CINRYZE (25 mL of CINRYZE/ 75 mL of normal saline) on Day 3, 5, 7, 9, 11, and 13 respectively. |
| DRUG | Placebo | Participants will receive 7 doses of matched placebo over 13 days of treatment. |
Timeline
- Start date
- 2016-05-20
- Primary completion
- 2019-05-31
- Completion
- 2019-05-31
- First posted
- 2015-09-11
- Last updated
- 2020-07-13
- Results posted
- 2020-07-13
Locations
47 sites across 6 countries: United States, Canada, France, Germany, Netherlands, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02547220. Inclusion in this directory is not an endorsement.