13-HMedIdeS-03

11 evidence topics · 2 sources

Objective

Primary study objective

“safety and tolerability” (opens the source at this quote in a new tab)

Location and study date

Country and recruitment start

Study characteristic	Quoted record
Country	“Sweden”
Recruitment start	“04 Jun 2015”

Study design

Masking

“Not blinded” (opens the source at this quote in a new tab)

Eligibility criteria

No evidence found.

Treatment

Intravenous dose groups

Group	Dose
First dose group	“0.25 mg/kg”
Second dose group	“0.50 mg/kg”

Study outcomes

Rationale for using safety parameters as the primary endpoint

Not applicable.

Statistical analysis description

Number of participants (Planned and analyzed)

Enrollment

Population	Participants
Screened	“12”
Enrolled	“10”

Description of analysis sets

Statistical approach

“descriptive statistics” (opens the source at this quote in a new tab)

Results

Participant disposition

Study completion

Disposition	First dose group	Second dose group
Completed	“5”	“5”

Baseline characteristics

Sex distribution

Characteristic	Participants
Female	“7”
Male	“3”

Efficacy results

HLA antibody levels acceptable for transplantation within 24 hours

Outcome	First dose group	Second dose group
Participants meeting the endpoint	“5”	“5”

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

Adverse events through the study follow-up period

Outcome	First dose group	Second dose group
Adverse events, total events	“52”	“54”

Study limitations

Summary

This unblinded study enrolled 10 participants in two dose groups of 5 and used descriptive analyses. It does not provide a randomized estimate of treatment effect. Its 52 and 54 adverse-event counts are numbers of events, not numbers of affected participants. The combined early-trial publication should not be added to this enrollment count as an independent population.