Hemolytic Uremic Syndrome
Conditions
Brief summary
Time to recovery of renal function during the acute phase. Defined as time (days) to achieve a GFR greater than or equal to the LLN (according to age, height, and sex) and a sCr less than or equal to the ULN (according to age and sex) measured in the absence of dialysis within the 28-day follow-up period.
Detailed description
Recovery of kidney function at the short-term - Proportion of subjects with GFR ≥ LLN of reference (according to age, height, and sex) and sCr ≤ ULN of reference (according to age and sex) measured in the absence of dialysis, at day 90., MAKE 90 - Proportion of subjects meeting any of the following criteria at day 90: death, dialysis requirement after 24 h post-randomization, dialysis for more than 10 days, or persistent decline in renal function (no recovery of expected GFR according to age, height, and sex)., Dialysis for more than 10 days - Proportion of dialyzed subjects requiring more than 10 days of dialysis., Incidence of dialysis. - Proportion of subjects requiring dialysis after 24 h post-randomization., Mortality. - Proportion of subjects who die due to any cause.
Interventions
DRUGANTI SHIGA TOXIN
DRUGSodium Chloride 0.9%
PLACEBO INM004 solution for injection (Placebo)
DRUGis a sterile normal saline solution packaged in glass vials containing sodium chloride at 0.9%
DRUGfor administration by intravenous infusion.
Sponsors
Chemo Research S.L., Inmunova S.A.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to recovery of renal function during the acute phase. Defined as time (days) to achieve a GFR greater than or equal to the LLN (according to age, height, and sex) and a sCr less than or equal to the ULN (according to age and sex) measured in the absence of dialysis within the 28-day follow-up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Recovery of kidney function at the short-term - Proportion of subjects with GFR ≥ LLN of reference (according to age, height, and sex) and sCr ≤ ULN of reference (according to age and sex) measured in the absence of dialysis, at day 90., MAKE 90 - Proportion of subjects meeting any of the following criteria at day 90: death, dialysis requirement after 24 h post-randomization, dialysis for more than 10 days, or persistent decline in renal function (no recovery of expected GFR according to age, height, and sex)., Dialysis for more than 10 days - Proportion of dialyzed subjects requiring more than 10 days of dialysis., Incidence of dialysis. - Proportion of subjects requiring dialysis after 24 h post-randomization., Mortality. - Proportion of subjects who die due to any cause. | — |
Countries
Belgium, France, Germany, Ireland, Italy, Netherlands, Romania, Spain
Outcome results
None listed