Trial Outcomes & Findings for Ides in Highly Sensitized (HS) Patients Awaiting Kidney Transplantation (NCT NCT02426684)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

17 participants

Primary outcome timeframe

6 months

Results posted on

2022-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	IdeS® 0.24mg/kg Twenty patients were planned to receive 0.24mg/kg (n=20). 17 patients in total were enrolled in this study. The study closed to enrollment before completing the intended 20 participant enrollment; with 3 allocations remaining.
Overall Study STARTED	17
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	IdeS® 0.24mg/kg Twenty patients were planned to receive 0.24mg/kg (n=20). 17 patients in total were enrolled in this study. The study closed to enrollment before completing the intended 20 participant enrollment; with 3 allocations remaining.
Overall Study Physician Decision	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IdeS® 0.24 mg/kg n=17 Participants patients who received 0.24mg/kg (n=17)
Age, Customized	41.6 years STANDARD_DEVIATION 13 • n=17 Participants
Sex: Female, Male Female	9 Participants n=17 Participants
Sex: Female, Male Male	8 Participants n=17 Participants
Region of Enrollment United States	17 participants n=17 Participants

PRIMARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	IdeS® 0.24 mg/kg n=13 Participants patients who received 0.24mg/kg (n=17)
Number of Participants With Allograft Rejection	7 Participants

SECONDARY outcome

Timeframe: 6 months post transplant

eGFR based on serum creatinine will be collected 6 months post transplant.

Outcome measures

Outcome measures
Measure	IdeS® 0.24 mg/kg n=13 Participants patients who received 0.24mg/kg (n=17)
eGFR	66 ml/min/m2 Standard Deviation 48

SECONDARY outcome

Timeframe: 6 months post transplant

Population: This outcome was not assessed

Urine total protein \& urine creatinine will be drawn from day 0 to day 30, and urinalysis will be collected on day 180 from transplant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months post transplant

Donor specific antibody levels will be checked at Day 180 post transplant to see if patients developed new antibodies or antibody intensity levels worsened post transplant. The DSA mean fluorescence intensity (MFI) was recorded, in comparison to the levels at transplant. This outcome measure was intended to record if any of the participants had a new DSA formation at Day 180, or if any participant had higher MFI levels of the DSA at Day 180, compared to baseline.

Outcome measures

Outcome measures
Measure	IdeS® 0.24 mg/kg n=14 Participants patients who received 0.24mg/kg (n=17)
Number of Participants With Donor Specific Antibodies (DSA) Post-transplant	4 Participants

Adverse Events

IdeS® 0.24 mg/kg

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IdeS® 0.24 mg/kg n=17 participants at risk patients who received 0.24mg/kg (n=17)
Infections and infestations Infection (UTI)	11.8% 2/17 • Number of events 2 • 6 months
General disorders Malignant hyperthermia	5.9% 1/17 • Number of events 1 • 6 months
Blood and lymphatic system disorders Fever and anemia	5.9% 1/17 • Number of events 1 • 6 months
Renal and urinary disorders moderate hydronephrosis and ureteral obstruction	5.9% 1/17 • Number of events 1 • 6 months
Gastrointestinal disorders abdominal pain, nausea, vomitting	11.8% 2/17 • Number of events 2 • 6 months
Renal and urinary disorders Elevated Cr and Afib with RVR after peritneal dialysis	5.9% 1/17 • Number of events 1 • 6 months
Cardiac disorders CHF exacerbation and AKI	5.9% 1/17 • Number of events 1 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Stanley C. Jordan, MD

Cedars Sinai Medical Center

Phone: 310-423-2641

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place