Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase II Study to Evaluate the Efficacy of IdeS to Desensitize Transplant Patients With a Positive Crossmatch Test (Highdes)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02790437
Recruitment Status : Completed
First Posted : June 3, 2016
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Hansa Biopharma AB

Brief Summary:
The purpose of this study is to evaluate the effectiveness of the study drug IdeS in patients who are on the waiting list for kidney transplant and have previously undergone desensitization unsuccessfully or in whom effective desensitization will be highly unlikely. At study entry, the patients will have an available deceased or live donor with a positive crossmatch test. The study will assess IdeS efficacy and safety in removing Donor Specific Antibodies (DSAs) and thereby convert a positive crossmatch test to negative.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Drug: IdeS Procedure: Kidney transplantation Phase 2

Detailed Description:
The study will assess the IdeS efficacy in creating a negative crossmatch test (CXM) in patients who exhibit donor specific antibodies (DSA) and have a positive crossmatch test to their available live or deceased donors. The first 3 patients in this study will receive a kidney from a deceased donor. The study will primarily examine the efficacy of IdeS in creating a negative CXM. The first 3 patients will receive one dose of 0.25 mg/kg BW IdeS on study day 0. If it is considered safe and negative crossmatch test is not achieved after the first dose, an additional IdeS infusion can be given within 2 days of the first infusion. The dose schedule may be increased to 0.5 mg/kg BW given once or twice after the first 3 patients have been tested. The decision to escalate the dose will be done after evaluation of safety and efficacy.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Evaluate the Efficacy of IdeS (IgG Endopeptidase) to Desensitize Transplant Patients With a Positive Crossmatch Test
Study Start Date : June 2016
Actual Primary Completion Date : December 12, 2017
Actual Study Completion Date : July 3, 2018

Arm Intervention/treatment
Experimental: Treatment IdeS
IdeS intravenous infusion
Drug: IdeS
One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion.
Other Name: IgG endopeptidase

Procedure: Kidney transplantation
Performed following IdeS treatment




Primary Outcome Measures :
  1. Efficacy on crossmatch conversion [ Time Frame: Within 24 hours of IdeS dosing ]
    IdeS ability to create a negative crossmatch test in patients who exhibit Donor Specific Antibodies (DSAs) and have a positive crossmatch test to their available live or deceased donor kidney


Secondary Outcome Measures :
  1. Efficacy on antibodies [ Time Frame: Within 48 hours.Time points 2, 6, 24 and 48 hours after administration of IdeS ]
    Donor specific antibodies (DSA) level at different time points

  2. Efficacy on CDC crossmatch test [ Time Frame: Within 24 hours ]
    Time to create a negative CDC crossmatch test

  3. Efficacy on FACS crossmatch test [ Time Frame: Within 24 hours ]
    Time to create a negative FACS crossmatch test

  4. Safety as assessed by Adverse events, clinical laboratory tests, vital signs [ Time Frame: 180 days ]
    Adverse events, clinical laboratory tests, vital signs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients on the kidney transplant waitlist who have previously undergone desensitization unsuccessfully or in whom effective desensitization will be highly unlikely. The breadth and strength of sensitization will predict an extremely low likelihood of successful desensitization or kidney paired donation.
  • Patients with a live or deceased donor with a positive crossmatch test.

Exclusion Criteria:

  • Previous treatment with IdeS
  • Previous high dose IVIg treatment (2 g/kg BW) within 28 days prior to IdeS treatment
  • Lactating or pregnant females
  • Women of child-bearing age who are not willing or able to practice FDA-approved forms of contraception
  • HIV-positive patients
  • Patients with clinical signs of HBV or HCV infection
  • Patients with active tuberculosis
  • A significantly abnormal general serum screening lab result according to the investigator's judgement. Hgb cannot be < 6.0 g/dL
  • Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure > NYHA (New York Heart Association) grade 3, unstable coronary disease or oxygen dependent COPD
  • Individuals deemed unable to comply with the protocol
  • Patients with clinical signs of CMV or EBV infection
  • Patients with a history of major thrombotic events, patients with active peripheral vascular disease or patients with proven hypercoagulable conditions
  • Patients should not have received investigational drugs within 4 half-lives (or similar)
  • Known allergy/sensitivity to IdeS infusions
  • Patients who have a live donor and test positive for ImmunoCap anti-IdeS IgE

Information from the National Library of Medicine

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): NCT02790437


Locations
Layout table for location information
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
France
Necker Hospital
Paris, France, 75743
Sweden
Uppsala University Hospital
Uppsala, Sweden, 75185
Sponsors and Collaborators
Hansa Biopharma AB
Investigators
Layout table for investigator information
Study Director: Lena Winstedt, PhD Hansa Biopharma AB

Layout table for additonal information
Responsible Party: Hansa Biopharma AB
ClinicalTrials.gov Identifier: NCT02790437     History of Changes
Other Study ID Numbers: 15-HMedIdeS-06
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic