13-HMedIdeS-02

10 evidence topics · 1 source

Objective

Study objectives

“Safety, immunogenicity, pharmacokinetics, and efficacy” (opens the source at this quote in a new tab)

Location and study date

No evidence found.

Study design

Dose-escalation design

“single-center, open-label ascending-dose study” (opens the source at this quote in a new tab)

Eligibility criteria

Kidney disease population

“chronic kidney disease” (opens the source at this quote in a new tab)

Treatment

Dose levels

Dose level	Quoted dose
Lower dose per infusion	“0.12 mg/kg”
Higher dose per infusion	“0.25 mg/kg”

Study outcomes

Rationale for using safety and tolerability as the primary endpoint

Not applicable.

Statistical analysis description

Number of participants (Planned and analyzed)

Enrolled population

Population	Participants
Enrolled	“Eight patients with cytotoxic PRAs (median cytotoxic PRAs of 64%) at enrollment received 1 or 2 intravenous infusions of IdeS on consecutive days”

Description of analysis sets

Pharmacokinetic model

“Pharmacokinetics was evaluated using an open 2‐compartment model.” (opens the source at this quote in a new tab)

Results

Participant disposition

No evidence found.

Baseline characteristics

Baseline sensitization

Characteristic	Quoted value
Median cytotoxic panel-reactive antibody	“64%”

Efficacy results

Pharmacodynamics: NCT02224820

“<1% plasma IgG remaining within 48 hours” (opens the source at this quote in a new tab)

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

Immunogenicity: NCT02224820

“Anti-IdeS antibodies developed 1 week after treatment, peaking at 2 weeks.” (opens the source at this quote in a new tab)

Study limitations

Summary

This single-center, open-label ascending-dose study enrolled 8 participants with chronic kidney disease. It establishes pharmacodynamic and immunogenicity observations in a small population, not a randomized estimate of transplantation benefit or long-term safety. IgG depletion within 48 hours and anti-IdeS antibody development are distinct outcomes and should not be equated with sustained clinical benefit.