A Phase II Study to Evaluate the Efficacy of IdeS to Desensitize Transplant Patients With a Positive Crossmatch Test
Highdes
1 other identifier
interventional
19
3 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2016
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2018
CompletedResults Posted
Study results publicly available
May 20, 2021
CompletedMay 20, 2021
April 1, 2021
1.5 years
May 30, 2016
February 22, 2021
April 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients With Crossmatch Conversion (Positive to Negative)
IdeS ability to create a negative crossmatch (XM) test in patients who before treatment exhibit Donor Specific Antibodies (DSAs) and have a positive XM test to their available live or deceased donor kidney. XM was assessed using both FACS and CDC XM tests. FACS XM is a multi-staining procedure where the recipient's serum is used to stain donor cells to identify presence of DSAs in recipient's serum. T- and B-cells are identified using conjugated antibodies against CD3 and CD19. DSAs are identified using a conjugated anti-human antibody. CDC XM evaluates the cytotoxic capacity of the DSAs. The recipient's serum is mixed with donor cells prior to addition of complement. Fluorescent dyes are added and the live/dead cells (%) is scored using a fluorescent microscope. CDC XM amplified with anti-human globulin is not compatible with imlifidase and should not be used. The endpoint was met if at least one XM test was positive pre-dose and the last test within 24 h was negative.
Within 24 hours of IdeS dosing
Secondary Outcomes (14)
Number of Patients With Donor Specific Antibodies With an MFI Value >3000
Within 180 days after administration of IdeS.
Time to Create a Negative CDC Crossmatch Test
2h, 6h, 24h after administration of IdeS.
Time to Create a Negative FACS Crossmatch Test
2h, 6h, and 24h after administration of IdeS
Kidney Function After IdeS Treatment Assessed by eGFR
Within 180 days after administration of IdeS
Serum IgG Concentration After Administration of IdeS
Within 180 days after administration of IdeS.
- +9 more secondary outcomes
Study Arms (1)
Treatment IdeS
EXPERIMENTALIdeS intravenous infusion
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21205, United States
New York University School of Medicine
New York, New York, 10016, United States
Necker Hospital
Paris, 75743, France
Uppsala University Hospital
Uppsala, 75185, Sweden
Related Publications (4)
Lorant T, Lonze BE, Montgomery RA, Desai NM, Legendre C, Lundgren T, von Zur-Muhlen B, Vo AA, Sjoholm K, Runstrom A, Tollemar J, Jordan SC. Five Years Follow-up of Imlifidase Desensitized Kidney Transplant Recipients. Transpl Int. 2025 Nov 27;38:15425. doi: 10.3389/ti.2025.15425. eCollection 2025.
PMID: 41394519DERIVEDJaffe IS, Runstrom A, Tatapudi VS, Weldon EP, Deterville CL, Dieter RA, Montgomery RA, Lonze BE, Mangiola M. Clinical Outcomes and Donor-specific Antibody Rebound 5 y After Kidney Transplant Enabled by Imlifidase Desensitization. Transplant Direct. 2025 Jan 9;11(2):e1752. doi: 10.1097/TXD.0000000000001752. eCollection 2025 Feb.
PMID: 39802198DERIVEDKjellman C, Maldonado AQ, Sjoholm K, Lonze BE, Montgomery RA, Runstrom A, Lorant T, Desai NM, Legendre C, Lundgren T, von Zur Muhlen B, Vo AA, Olsson H, Jordan SC. Outcomes at 3 years posttransplant in imlifidase-desensitized kidney transplant patients. Am J Transplant. 2021 Dec;21(12):3907-3918. doi: 10.1111/ajt.16754. Epub 2021 Jul 19.
PMID: 34236770DERIVEDJordan SC, Legendre C, Desai NM, Lorant T, Bengtsson M, Lonze BE, Vo AA, Runstrom A, Laxmyr L, Sjoholm K, Schiott A, Sonesson E, Wood K, Winstedt L, Kjellman C, Montgomery RA. Imlifidase Desensitization in Crossmatch-positive, Highly Sensitized Kidney Transplant Recipients: Results of an International Phase 2 Trial (Highdes). Transplantation. 2021 Aug 1;105(8):1808-1817. doi: 10.1097/TP.0000000000003496.
PMID: 33093408DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Elisabeth Sonesson, Director Clinical Operations
- Organization
- Hansa Biopharma AB
Study Officials
- STUDY DIRECTOR
Lena Winstedt, PhD
Hansa Biopharma AB
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2016
First Posted
June 3, 2016
Study Start
June 1, 2016
Primary Completion
December 12, 2017
Study Completion
July 3, 2018
Last Updated
May 20, 2021
Results First Posted
May 20, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share