Highdes

15 evidence topics · 3 sources

Objective

Desensitization objective

“converting a positive crossmatch test to negative” (opens the source at this quote in a new tab)

Location and study date

Recruitment start and participating countries

Study characteristic	Quoted record
Recruitment start	“30 Sep 2016”
Participating country	“Sweden”
Participating country	“France”
Participating country	“United States”

Study design

“open-label, single-arm, phase 2” (opens the source at this quote in a new tab)

Eligibility criteria

Transplant donor eligibility

“a living or deceased donor kidney” (opens the source at this quote in a new tab)

Treatment

Dosing groups

Regimen	Dose
Single intravenous infusion	“0.25 mg/kg”
Two intravenous infusions	“2 x 0.25 mg/kg”

Study outcomes

Rationale for using crossmatch conversion within 24 hours as the primary endpoint

Crossmatch conversion and access to transplantation

“allowing highly sensitized patients to be transplanted” (opens the source at this quote in a new tab)

Statistical analysis description

Number of participants (Planned and analyzed)

Screened and enrolled populations

Population	Participants
Screened	“21”
Enrolled	“19”

Description of analysis sets

Registry analysis populations and statistical approach

Analysis	Quoted record
Primary efficacy analysis set	“Full analysis”
Primary endpoint analysis population	“19”
Endpoint summaries	“descriptive statistics”

Results

Participant disposition

Completion by dosing group

Disposition	One infusion	Two infusions
Started	“16”	“3”
Completed	“13”	“3”

Baseline characteristics

Median sensitization

Baseline characteristic	Quoted value
Median calculated panel-reactive antibody	“99.83%”

Efficacy results

Highdes, NCT02790437: crossmatch conversion

“89.5% demonstrated conversion of baseline positive crossmatch to negative within 24 h” (opens the source at this quote in a new tab)

Long-term follow-up: survival

“At 5 y, 7 of 8 participants were alive.” (opens the source at this quote in a new tab)

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

Highdes, NCT02790437: antibody-mediated rejection

“38.9% had early biopsy proven antibody-mediated rejection” (opens the source at this quote in a new tab)

Long-term follow-up: antibody-mediated rejection

“No new episodes of suspected or biopsy-proven AMR occurred after 30 d posttransplant.” (opens the source at this quote in a new tab)

Study limitations

Summary

Highdes enrolled 19 participants without a randomized control group. Its primary endpoint was crossmatch conversion, which enables transplantation but does not alone establish long-term graft survival or freedom from rejection. The five-year single-site report concerns 8 participants from the same trial, not an additional independent trial population.