Trial · NCT05876351
Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China
NCT05876351, Phase 3, Completed, Alexion Pharmaceuticals, Inc.; results first posted 2025-12-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China. Trials, record NCT05876351. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05876351
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China
- NCT number
- NCT05876351
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 25 participants, actual
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Conditions
- Atypical Hemolytic Uremic
- Interventions
- Eculizumab
- First posted
- 2023-05-25
- Last updated
- 2025-12-08
- Other registries' IDs
- eudract:2025-000162-29
- Results first posted
- 2025-12-08
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Complete Thrombotic Microangiopathy (TMA) Response | Up to Week 26 | Full Analysis Set: Included all participants who received at least 1 dose of study intervention and had at least 1 efficacy assessment post first dose. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With an Adverse Event (AE) | Up to Week 34 | Safety Set: Included all participants who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Serum Concentration of Eculizumab | Pre-dose and post-dose at Days 1, 8, 29, 85, and 141; Pre-dose at Day 183 | Pharmacokinetic (PK) Analysis Set: Included all participants who received at least 1 dose of study intervention and had evaluable pharmacokinetic data. 'Number Analyzed' = number of participants evaluable at specified timepoint. | micrograms per milliliter (ug/mL) | GEOMETRIC_MEAN |
| 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 | Pharmacodynamic (PD) Analysis Set: Included all participants who received at least 1 dose of study intervention and had evaluable PD data. 'Number Analyzed' = number of participants evaluable at specified timepoint. | ug/mL | MEAN |
| 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 | PD Analysis Set: Included all participants who received at least 1 dose of study intervention and had evaluable PD data. 'Number Analyzed' = number of participants evaluable at specified timepoint. | ug/mL | MEAN |
| SECONDARY | Number of Participants With an Anti-drug Antibody (ADA) Response | Up to Week 26 | Safety Set: Included all participants who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Complete TMA Response | Up to Week 26 | Full Analysis Set: Included all participants who received at least 1 dose of study intervention and had at least 1 efficacy assessment post first dose. | days | MEDIAN |
| SECONDARY | Proportion of Participants On or Off Dialysis at Each Timepoint | Baseline and Days 22, 43, 71, 99, 113, 127, 155 and 183 | Full Analysis Set: Included all participants who received at least 1 dose of study intervention and had at least 1 efficacy assessment post first dose. 'Number Analyzed' = number of participants evaluable at specified timepoint. | proportion of participants | NUMBER |
| 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 | Full Analysis Set: Included all participants who received at least 1 dose of study intervention and had at least 1 efficacy assessment post first dose. 'Number Analyzed' = number of participants evaluable at the specific timepoint. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at the specific timepoint. | mL/min/1.73^2 | MEAN |
| 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 | Full Analysis Set: Included all participants who received at least 1 dose of study intervention and had at least 1 efficacy assessment post first dose. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at specified timepoint. | proportion of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group110
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Complete Thrombotic Microangiopathy (TMA) Response | Eculizumab | 64.0 | 95% Confidence Interval 42.5 | percentage of participants | |
| Number of Participants With an Adverse Event (AE) | Eculizumab | Any AE | 24 | Participants | |
| Number of Participants With an Adverse Event (AE) | Eculizumab | Any SAE | 8 | Participants | |
| Mean Serum Concentration of Eculizumab | Eculizumab | Day 1: Pre-dose | 4.690 | Geometric Coefficient of Variation 0.00 | micrograms per milliliter (ug/mL) |
| Mean Serum Concentration of Eculizumab | Eculizumab | Day 1: Post-dose | 373.423 | Geometric Coefficient of Variation 47.59 | micrograms per milliliter (ug/mL) |
| Mean Serum Concentration of Eculizumab | Eculizumab | Day 8: Pre-dose | 153.190 | Geometric Coefficient of Variation 69.69 | micrograms per milliliter (ug/mL) |
| Mean Serum Concentration of Eculizumab | Eculizumab | Day 8: Post-dose | 498.262 | Geometric Coefficient of Variation 41.18 | micrograms per milliliter (ug/mL) |
| Mean Serum Concentration of Eculizumab | Eculizumab | Day 29: Pre-dose | 353.726 | Geometric Coefficient of Variation 36.96 | micrograms per milliliter (ug/mL) |
| Mean Serum Concentration of Eculizumab | Eculizumab | Day 29: Post-dose | 727.862 | Geometric Coefficient of Variation 32.22 | micrograms per milliliter (ug/mL) |
| Mean Serum Concentration of Eculizumab | Eculizumab | Day 85: Pre-dose | 360.070 | Geometric Coefficient of Variation 43.89 | micrograms per milliliter (ug/mL) |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Eculizumab | 25 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Eculizumab | 25 | |
| Overall Study | COMPLETED | Eculizumab | 22 | |
| Overall Study | NOT COMPLETED | Eculizumab | 3 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bronchitis | Infections and infestations | Eculizumab | 2 | 25 | 2 |
| other | Infection | Infections and infestations | Eculizumab | 3 | 25 | 4 |
| other | Influenza | Infections and infestations | Eculizumab | 2 | 25 | 2 |
| other | Respiratory tract infection | Infections and infestations | Eculizumab | 4 | 25 | 5 |
| other | Upper respiratory tract infection | Infections and infestations | Eculizumab | 5 | 25 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Eculizumab | 2 | 25 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | Eculizumab | 2 | 25 | 2 |
| other | Electrolyte imbalance | Metabolism and nutrition disorders | Eculizumab | 2 | 25 | 2 |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Eculizumab | 7 | 25 | 9 |
| other | Hyperphosphataemia | Metabolism and nutrition disorders | Eculizumab | 3 | 25 | 3 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eculizumab | 0 | 25 |
| Total, other adverse events | Eculizumab | 24 | 25 |
| Total, serious adverse events | Eculizumab | 8 | 25 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
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