Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT03221842|
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : June 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Antibody-mediated Rejection||Drug: C1-esterase inhibitor Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Randomized-withdrawal|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Randomized-withdrawal, Placebo-controlled Study to Evaluate the Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection in Adult Renal Transplant Recipients|
|Actual Study Start Date :||November 6, 2017|
|Estimated Primary Completion Date :||July 16, 2020|
|Estimated Study Completion Date :||October 16, 2023|
Drug: C1-esterase inhibitor
C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution
Other Name: C1-INH
Placebo Comparator: Placebo
Excipients of C1-INH plus albumin
Excipients of C1-INH plus albumin
- Time to loss of response during Treatment Period 2 [ Time Frame: Up to approximately 25 weeks ]
Loss of response is defined as 1 of the following, whichever occurs first:
- Decline in Estimated Glomerular Filtration Rate (eGFR), or
- Allograft failure, or
- Subject death by any cause.
- Time to all-cause allograft failure through the follow-up period for both Treatment Period 1 responders and non-responders [ Time Frame: Up to approximately 208 weeks ]
Allograft failure is defined as 1 of the following, whichever occurs first:
- Allograft nephrectomy.
- Permanent dialysis.
- Return to the transplant waitlist.
- Percentage of subjects with response to treatment at the end of Treatment Period 1 [ Time Frame: Up to approximately 13 weeks ]Response is defined as an increase in eGFR.
- Percentage of subjects with sustained improvement of eGFR during Treatment Period 2 [ Time Frame: Up to approximately 25 weeks ]Sustained improvement is defined as an increase in eGFR
- Change from screening in Banff category scores at up to 38 weeks [ Time Frame: Screening and up to approximately 38 weeks ]Banff category scores are used to grade the histopathology of kidney allograft biopsies using a scoring system of 0 (best possible) to 3 (worst possible)
- Percentage of subjects with splenectomy during Treatment Period 1 and during Treatment Period 2 [ Time Frame: Up to approximately 38 weeks ]
- Percentage of subjects with allograft survival through the follow-up period [ Time Frame: Up to approximately 208 weeks ]
- Time to subject death through the follow-up period [ Time Frame: Up to approximately 208 weeks ]
- Percentage of subjects with any adverse event (AE) assessed as related to investigational product [ Time Frame: Up to approximately 42 weeks after the time of first investigational product administration ]
- Pre-dose C1-INH functional activity [ Time Frame: Day 1, approximately Week 12, and approximately Week 38 ]
- Time to maximum plasma concentration (Cmax) for C1-INH functional activity [ Time Frame: Up to 72 hours after dose ]
- Area under the plasma concentration time curve (AUC0-t) for C1-INH functional activity [ Time Frame: Up to 72 hours after dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221842
|Contact: Clinical Trial Registration Coordinatorfirstname.lastname@example.org|
Show 24 Study Locations
|Study Director:||Program Director||CSL Behring|