Completed PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT01134510

Safety & Tolerability of Berinert® (C1 Inhibitor) Therapy to Prevent Rejection

A Phase I/II Trial to Evaluate the Safety & Tolerability of Berinert® (C1 Inhibitor) Therapy to Prevent Complement-Dependent, Antibody-Mediated Rejection Post-Transplant in Highly-HLA Sensitized Patients

Sponsor: CSL Behring

Conditions Kidney Transplantation

Interventions C1 Esterase Inhibitor Placebos

Updated 9 times since 2017 Last updated: Feb 16, 2017 Started: Aug 31, 2011 Primary completion: Nov 30, 2013 Completion: Nov 30, 2013

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Kidney Transplantation and is currently completed. CSL Behring leads this study, which shows 9 recorded versions since 2011 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

9 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1/PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1/PHASE2

Phase: PHASE1_PHASE2 → PHASE1/PHASE2
Jan 2023 — Jul 2024 [monthly]

Completed PHASE1_PHASE2
Dec 2022 — Jan 2023 [monthly]

Completed PHASE1_PHASE2
Jan 2021 — Dec 2022 [monthly]

Completed PHASE1_PHASE2

▶ Show 4 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE1_PHASE2
May 2017 — Jun 2018 [monthly]

Completed PHASE1_PHASE2
Feb 2017 — May 2017 [monthly]

Completed PHASE1_PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE1_PHASE2

First recorded

Aug 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

CSL Behring
Stanley Jordan, MD

Data source: Cedars-Sinai Medical Center

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Los Angeles, United States