A Phase 2, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Efficacy, and Tolerability of ARGX-117 in Improving Allograft Function in Recipients of a Deceased Donor Renal Allograft at Risk for Delayed Graft Function (Varvara)

Conditions

Delayed graft function

Brief summary

eGFR at 24 weeks posttransplant

Detailed description

Proportion of participants with DGF, Proportion of participants with fDGF, Duration of dialysis treatment for DGF within the first 30 days posttransplant (ie, date of last dialysis treatment), CRR at 72 hours posttransplant and on study day 8, iBox score at 52 weeks posttransplant, Dialysis-free participant survival through 52 weeks posttransplant, eGFR at 52 weeks posttransplant, Safety outcomes, including AE and AESI incidence, vital sign measurements, clinical laboratory tests, Incidence of PNF, Serum concentrations and PK parameters for ARGX-117, Values and changes from baseline in free C2, total C2, and CH50 activity, Incidence and prevalence of ADA against ARGX-117, Proportion of participants who have ongoing dialysis requirement at study day 31, (Death-censored) allograft survival through 52 weeks posttransplant

Related papers

No related papers found yet.

Interventions

DRUGARGX-117

DRUGPlacebo to ARGX-117 IV concentrate solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
eGFR at 24 weeks posttransplant	—

Secondary

Measure	Time frame
Proportion of participants with DGF, Proportion of participants with fDGF, Duration of dialysis treatment for DGF within the first 30 days posttransplant (ie, date of last dialysis treatment), CRR at 72 hours posttransplant and on study day 8, iBox score at 52 weeks posttransplant, Dialysis-free participant survival through 52 weeks posttransplant, eGFR at 52 weeks posttransplant, Safety outcomes, including AE and AESI incidence, vital sign measurements, clinical laboratory tests, Incidence of PNF, Serum concentrations and PK parameters for ARGX-117, Values and changes from baseline in free C2, total C2, and CH50 activity, Incidence and prevalence of ADA against ARGX-117, Proportion of participants who have ongoing dialysis requirement at study day 31, (Death-censored) allograft survival through 52 weeks posttransplant	—

Measure

Time frame

Proportion of participants with DGF, Proportion of participants with fDGF, Duration of dialysis treatment for DGF within the first 30 days posttransplant (ie, date of last dialysis treatment), CRR at 72 hours posttransplant and on study day 8, iBox score at 52 weeks posttransplant, Dialysis-free participant survival through 52 weeks posttransplant, eGFR at 52 weeks posttransplant, Safety outcomes, including AE and AESI incidence, vital sign measurements, clinical laboratory tests, Incidence of PNF, Serum concentrations and PK parameters for ARGX-117, Values and changes from baseline in free C2, total C2, and CH50 activity, Incidence and prevalence of ADA against ARGX-117, Proportion of participants who have ongoing dialysis requirement at study day 31, (Death-censored) allograft survival through 52 weeks posttransplant

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Countries

Austria, Belgium, France, Italy, Portugal, Spain, Sweden

Outcome results

None listed