Have you or your loved ones been diagnosed with antibody-mediated rejection?

You may be eligible to participate in a antibody-mediated rejection clinical trial.

Have you or your loved ones been diagnosed with antibody-mediated rejection? You may be eligible to participate in a antibody-mediated rejection clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Antibody-mediated Rejection Clinical Trial

NCT03221842 | Phase 3 | Interventional

Have you or your loved ones been diagnosed with antibody-mediated rejection?

You may be eligible to participate in a antibody-mediated rejection clinical trial.

Have you or your loved ones been diagnosed with antibody-mediated rejection? You may be eligible to participate in a antibody-mediated rejection clinical trial.

Terminated

Male & Female

18 Years +

This study has recruited 63 Participants

This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).

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Details for the study

Brief Title

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

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

Brief Summary

Treatments and/or Procedures

Placebo

Excipients of C1-INH plus albumin

C1 esterase inhibitor

C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Percent of Participants With Loss-of-response During Treatment Period 2 (TP2)

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.

Up to 38 weeks

Secondary

Number of Participants With All-cause Allograft Failure During TP2

Allograft failure is defined as 1 of the following: Allograft nephrectomy, institution of permanent dialysis, or return to the transplant waitlist for renal transplant, whichever occurs first, OR Subject death by any cause

Up to 38 weeks

Secondary

Number of Responders at the End-of-TP1

Responders were defined as subjects whose End-of-TP1 eGFR was ≥ 90% of baseline eGFR and ≥ 20 mL/min/1.73 m2.

Up to 13 weeks

Secondary

The Rate of Change of eGFR During TP2 as Defined by the Slope of the Mean Regression of eGFR Over Time at End of TP2

The Sponsor terminated the study due to futility of enrolment. Because of the study termination, limited efficacy results are presented in this report.

Up to 38 weeks

Secondary

Time to All-cause Allograft Failure Through the Follow up Period

The Sponsor terminated the study due to futility of enrolment. Because of the study termination, limited efficacy results are presented in this report.

Up to approximately 208 weeks

Secondary

Percent of Responders at the End-of-TP1

Responders were defined as subjects whose End-of-TP1 eGFR was ≥ 90% of baseline eGFR and ≥ 20 mL/min/1.73 m2.

Up to 13 weeks

Secondary

Proportion of Subjects Surviving Through the Follow-up Period

The Sponsor terminated the study due to futility of enrolment. Because of the study termination, limited efficacy results are presented in this report.

Up to approximately 208 weeks

Secondary

Mean Pre-dose C1-esterase Inhibitor Functional Activity

C1-esterase Inhibitor may play a role in the prevention of antibody-mediated rejection (AMR) following kidney transplant. Low levels of C1 esterase inhibitor concentration and its functional activity may lead to AMR. Patients with AMR may go on to lose their kidney transplant and have other associated health risks. Levels of C1-esterase inhibitor functional activity in plasma is described as a percent.

Up to 13 weeks

Secondary

Area Under the Plasma Concentration Time Curve (AUC0-t) for C1-INH Functional Activity

Up to 72 hours after post-dose on Day 10 and on Day 77 of Period 1

Study Criteria

Inclusion Criteria:

Male or female at least 18 years of age;
Evidence of at least one donor-specific antibody (DSA);
Recipient of a kidney transplant;
Achieved a steady-state, post-transplant eGFR ≥ 40 mL/min/1.73 m2 within 60 days of post-transplant OR a 50% increase in urine output with a 50% decrease in serum creatinine over the first 7 days post-transplant in subjects with slow or delayed graft function;
Acute AMR.

Exclusion Criteria:

Recipient of an en bloc kidney transplant;
Current active hepatitis C virus (HCV) infection;
Active bacterial or fungal infection;
Ongoing dialysis >2 weeks;
Known congenital bleeding or coagulopathy disorder;
Current cancer or a history of cancer;
Female subjects who are pregnant or breast feeding;
Male or female subjects who are unwilling to use contraception or who are not surgically sterile.