Ides in Highly Sensitized (HS) Patients Awaiting Kidney Transplantation

NCT02426684 | Completed Phase 1 Results DMC

• 1 other identifier: IdeSCSMC
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center phase I/II open label, exploratory study assessing safety and efficacy of IdeS® (Hansa Medical, Lund, Sweden) given immediately prior to kidney transplantation. We hope that IdeS® will help eliminate DSAs in HS patients who are DSA+ and flow cytometry (FCMX) crossmatch + at time of transplant. We plan to enroll a total of 20 patients. Patients will be followed for 6 months post administration of IdeS®.

Conditions

Renal Disease

Keywords

End Stage Renal Disease; Kidney Transplant; Desensitization; Highly Sensitized; Antibodies

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Allograft Rejection

  Number of participants with allograft rejection will be assessed at 6 month post transplant renal biopsy.

  6 months

Secondary Outcomes (3)

• eGFR

  6 months post transplant

• Proteinuria

  6 months post transplant

• Number of Participants With Donor Specific Antibodies (DSA) Post-transplant

  6 months post transplant

Study Arms (1)

IdeS®

EXPERIMENTAL

Twenty patients will receive 0.24mg/kg (n=20)

Drug: IdeS® (Imlifidase)

Interventions

IdeS® (Imlifidase) DRUG

0.24mg/kg IdeS

Also known as: IgG endopeptidase

IdeS®

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• End-stage renal disease awaiting transplantation on the UNOS list.
• No known contraindications for therapy with IVIG10%/Rituximab, plasmapheresis (PLEX) or IdeS®.
• Age 18-70 years at the time of screening.
• Calculated PRA (CPRA)\> 50% demonstrated on 3 consecutive samples, Patient highly-HLA sensitized and a candidate for DD transplantation after desensitization at CSMC.
• At transplant, patient must have donor-specific antibody/ crossmatch positive (DSA/CMX+) non-HLA identical donor.
• Pre-transplant vaccination with Streptococcus pneumoniae and Nisseria meningitides
• Subject/Parent/Guardian must be able to understand and provide informed consent.

You may not qualify if:

• Positivity for anti-IdeS IgE
• Use of IVIG 4 weeks prior to planned IdeS® administration
• Recipients of Extended Criteria Donors (ECD) or Living Donors (LD)
• Lactating or pregnant females.
• Women of child-bearing age who are not willing or able to practice FDA-approved forms of contraception.
• HIV-positive subjects.
• Subjects who test positive for HBV infection \[positive HBVsAg, HBVcAb, or HBVeAg/DNA\] or HCV infection \[positive Anti-HCV (EIA) and confirmatory HCV RIBA\].
• Subjects with active TB.
• Subjects with selective IgA deficiency, those who have known anti-IgA antibodies, and those with a history of anaphylaxis or severe systemic responses to any part of the clinical trial material.
• Subjects who have received or for whom multiple organ transplants are planned.
• Recent recipients of any licensed or investigational live attenuated vaccine(s) within two months of the screening visit (including but not limited to any of the following:
• Adenovirus \[Adenovirus vaccine live oral type 7\]
• Varicella \[Varivax\]
• Hepatitis A \[VAQTA\]
• Rotavirus \[Rotashield\]

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Hansa Biopharma AB: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (2)

• von Pawel-Rammingen U. Streptococcal IdeS and its impact on immune response and inflammation. J Innate Immun. 2012;4(2):132-40. doi: 10.1159/000332940. Epub 2012 Jan 17.

  PMID: 22248585 BACKGROUND

• Jordan SC, Lorant T, Choi J, Kjellman C, Winstedt L, Bengtsson M, Zhang X, Eich T, Toyoda M, Eriksson BM, Ge S, Peng A, Jarnum S, Wood KJ, Lundgren T, Wennberg L, Backman L, Larsson E, Villicana R, Kahwaji J, Louie S, Kang A, Haas M, Nast C, Vo A, Tufveson G. IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation. N Engl J Med. 2017 Aug 3;377(5):442-453. doi: 10.1056/NEJMoa1612567.

  PMID: 28767349 DERIVED

MeSH Terms

Conditions

Kidney Diseases; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Stanley C. Jordan, MD
• Organization: Cedars Sinai Medical Center

sjordan@cshs.org

310-423-2641

Study Officials

• Stanley C Jordan, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: April 27, 2015
• Study Start: June 16, 2015
• Primary Completion: November 10, 2017
• Study Completion: November 10, 2017
• Last Updated: May 16, 2022
• Results First Posted: May 16, 2022

Record last verified: 2022-04

Locations

US (1)