CompletedPhase 1/2

Ides in Highly Sensitized (HS) Patients Awaiting Kidney Transplantation

United States17 participantsStarted 2015-06-16

Plain-language 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®.

Who can participate

Age range18 Years – 70 Years

SexALL

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Exclusion criteria

✕. Adenovirus \[Adenovirus vaccine live oral type 7\]
✕. Varicella \[Varivax\]
✕. Hepatitis A \[VAQTA\]
✕. Rotavirus \[Rotashield\]
✕. Yellow fever \[Y-F-Vax\]
✕. Measles and mumps \[Measles and mumps virus vaccine live\]
✕. Measles, mumps, and rubella vaccine \[M-M-R-II\]
✕. Sabin oral polio vaccine

What they're measuring

Number of Participants With Allograft Rejection

Timeframe: 6 months

Trial details

NCT IDNCT02426684

SponsorCedars-Sinai Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-11-10

Results submitted2021-04-22

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