Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 13 of 13

List	Outcome	Time frame	Description
Primary	Percentage of Participants With a Complete Thrombotic Microangiopathy (TMA) Response	Up to Week 26	The criteria for complete TMA response were: 1. Normalization of platelet count (defined as platelet count ≥ 150000/microliter (ul). 2. Normalization of lactate dehydrogenase (LDH, defined as LDH ≤ upper limit of normal \[ULN\]). 3. ≥ 25% improvement in serum creatinine from baseline.
Secondary	Number of Participants With an Adverse Event (AE)	Up to Week 34	An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: * resulted in death, * was life-threatening, * required inpatient hospitalization or prolongation of existing hospitalization, * resulted in persistent disability/incapacity, * was a congenital anomaly/birth defect, or * was an important medical event. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Adverse Events' Section.
Secondary	Mean Serum Concentration of Eculizumab	Pre-dose and post-dose at Days 1, 8, 29, 85, and 141; Pre-dose at Day 183
Secondary	Change From Baseline in Serum Free Complement 5 (C5)	Baseline (Day 1 pre-dose) to Days 1, 8, 29, 85 and 141 (pre-dose and post-dose) and pre-dose at Day 183
Secondary	Change From Baseline in Serum Total C5	Baseline (Day 1 pre-dose) to Days 1, 8, 29, 85 and 141 (pre-dose and post-dose) and pre-dose at Day 183
Secondary	Number of Participants With an Anti-drug Antibody (ADA) Response	Up to Week 26	An ADA response was defined as a positive ADA sample at any time during the study.
Secondary	Time to Complete TMA Response	Up to Week 26	Time to complete TMA response was defined as the time from first infusion to the first time point at which all criteria for complete TMA response was met. The criteria for complete TMA response were: 1. Normalization of platelet count (defined as platelet count ≥ 150000/ul. 2. Normalization of LDH, defined as LDH ≤ ULN). 3. ≥ 25% improvement in serum creatinine from baseline. Participants who did not have a response were censored at the date of last visit or study discontinuation at the time when the analysis was performed.
Secondary	Proportion of Participants On or Off Dialysis at Each Timepoint	Baseline and Days 22, 43, 71, 99, 113, 127, 155 and 183	Participants were considered as 'off' dialysis at a specific time point if they were dialysis free for more than 5 days prior to that time point. Participants were considered as 'on' dialysis at a specific time point if they were dialysis free to 5 days or less up prior to that time point.
Secondary	Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Each Scheduled Visit	Baseline, Days 22, 43, 71, 99, 113, 127, 155 and 183	Expressed in milliliters per minute per 1.73 square meters of body surface area.
Secondary	Proportion of Participants With a Chronic Kidney Disease (CKD) Stage Shift Categorized as "Improved", "Stable", or "Worsened" at Each Scheduled Visit Compared to Baseline	Baseline to Days 22, 43, 71, 99, 113, 127, 155 and 183	CKD stage was classified based on the National Kidney Foundation Chronic Kidney Disease Stage where Stage 5 represents the most severe disease and Stage 1 represents the least severe disease. "Improved" excluded participants with Stage 1 at baseline as there was no room for improvement. "Worsened" excludes participants with Stage 5 at baseline as there was no room to worsen.
Secondary	Change From Baseline in Platelets	Baseline, Days 22, 43, 71, 99, 113, 127, 155, and 183	Platelet values obtained from the day of a blood transfusion of platelets through 3 days after the transfusion are excluded from all analysis.
Secondary	Change From Baseline in LDH	Baseline, Days 22, 43, 71, 99, 113, 127, 155, and 183
Secondary	Change From Baseline in Hemoglobin	Baseline, Days 22, 43, 71, 99, 113, 127, 155, and 183	Hemoglobin values obtained from the day of a blood transfusion of either whole blood or packed red blood cells through 7 days after the transfusion are excluded from all analysis.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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