Phase 2
N=19
A Phase II Study to Evaluate the Efficacy of IdeS to Desensitize Transplant Patients With a Positive Crossmatch Test
Kidney Failure, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT02790437 ↗Enrolled (actual)
19
Serious AEs
79.0%
Results posted
May 2021
Primary outcome: Primary: Number of Patients With Crossmatch Conversion (Positive to Negative) — 17; 2 Patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IdeS (Drug); Kidney transplantation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hansa Biopharma AB
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Crossmatch Conversion (Positive to Negative) |
17; 2 | — |
| SECONDARY Number of Patients With Donor Specific Antibodies With an MFI Value >3000 |
17; 7; 3; 3; 3; 6 | — |
| SECONDARY Time to Create a Negative CDC Crossmatch Test |
6; 3 | — |
| SECONDARY Time to Create a Negative FACS Crossmatch Test |
8; 2; 7; 2 | — |
| SECONDARY Kidney Function After IdeS Treatment Assessed by eGFR |
5; 9; 4; 4; 7; 6 | — |
| SECONDARY Serum IgG Concentration After Administration of IdeS |
10.11; 8.35; 9.79; 1.19; 0.68; 1.08 | — |
| SECONDARY Pharmacokinetics - Cmax (First Dose) |
3.95 | — |
| SECONDARY Pharmacokinetics - Cmax (Second Dose) |
4.13 | — |
| SECONDARY Pharmacokinetics - Tmax (First Dose) |
2.21 | — |
| SECONDARY Pharmacokinetics - Tmax (Second Dose) |
15.98 | — |
| SECONDARY Pharmacokinetics - AUC |
156.09 | — |
| SECONDARY Pharmacokinetics - t1/2 |
4.58; 76.30 | — |
| SECONDARY Pharmacokinetics - CL |
1.60 | — |
| SECONDARY Pharmacokinetics - Vss |
0.14 | — |
| SECONDARY Pharmacokinetics - Vz |
0.19 | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT02790437). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.