Trial · NCT04784455
Nomacopan (rVA576) in Transplant Associated Thrombotic Microangiopathy
NCT04784455, Phase 3, Terminated, AKARI Therapeutics; results first posted 2025-05-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nomacopan (rVA576) in Transplant Associated Thrombotic Microangiopathy. Trials, record NCT04784455. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04784455
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nomacopan (rVA576) in Transplant Associated Thrombotic Microangiopathy
- NCT number
- NCT04784455
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 10 participants, actual
- Lead sponsor
- AKARI Therapeutics
- Conditions
- Thrombotic Microangiopathies
- Interventions
- nomacopan (rVA576)
- First posted
- 2021-03-05
- Last updated
- 2025-06-05
- Results first posted
- 2025-05-15
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants NOT Requiring a Red Blood Bell Transfusion (Transfusion Independence) for 28 Days or More OR Number of Participants With a Urine Protein Creatinine Ratio Value of ≤ 2 mg/mg Maintained for 28 Days or More. | 24 weeks | Red blood cell transfusion independence for ≥28 days immediately prior to any scheduled clinical visit up to Week 24 or Urine protein creatinine ratio ≤ 2 mg/mg maintained over ≥ 28 days immediately prior to any scheduled clinical visit up to week 24 Transfusion independence is defined as no RBC transfusion attributable to, or required to manage, thrombotic microangiopathy (TMA). Transfusions required for causes other than TMA will not be considered within the evaluation of the efficacy endpoints. |
| Secondary | Number of Participants With a Normalised sC5b-9 Value (Where sC5b-9 is the Same Value as the Upper Limit of Normal or Less) | 24 weeks | Plasma sC5b-9 ≤ upper limit of normal (ULN) |
| Secondary | Number of Participants With a Normalised Lactate Dehydrogenase (LDH) Value (Where LDH is the Same Value as the Upper Limit of Normal or Less) | 24 weeks | Lactate dehydrogenase (LDH) ≤ULN |
| Secondary | Normalisation of Lab Parameters | 24 weeks | Number of participants with a normalised haptoglobin value (where haptoglobin is within the normal ranges) |
| Secondary | Number of Participants Not Requiring a Platelet Transfusion (Transfusion Independence) for 28 Days or More. | 24 weeks | Transfusion independence is defined as no platelet transfusion attributable to, or required to manage, thrombotic microangiopathy (TMA). Transfusions required for causes other than TMA will not be considered within the evaluation of the efficacy endpoints. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants NOT Requiring a Red Blood Bell Transfusion (Transfusion Independence) for 28 Days or More OR Number of Participants With a Urine Protein Creatinine Ratio Value of ≤ 2 mg/mg Maintained for 28 Days or More. | 24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Normalised sC5b-9 Value (Where sC5b-9 is the Same Value as the Upper Limit of Normal or Less) | 24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Normalised Lactate Dehydrogenase (LDH) Value (Where LDH is the Same Value as the Upper Limit of Normal or Less) | 24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Normalisation of Lab Parameters | 24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Not Requiring a Platelet Transfusion (Transfusion Independence) for 28 Days or More. | 24 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Participants NOT Requiring a Red Blood Bell Transfusion (Transfusion Independence) for 28 Days or More OR Number of Participants With a Urine Protein Creatinine Ratio Value of ≤ 2 mg/mg Maintained for 28 Days or More. | Nomacopan | RBC transfusion independent for ≥ 28 days | 2 | Participants | |
Number of Participants NOT Requiring a Red Blood Bell Transfusion (Transfusion Independence) for 28 Days or More OR Number of Participants With a Urine Protein Creatinine Ratio Value of ≤ 2 mg/mg Maintained for 28 Days or More. | Nomacopan | Urine protein creatinine ratio (UPCR) ≤ 2 mg/mg for ≥ 28 days | 4 | Participants | |
| Number of Participants With a Normalised sC5b-9 Value (Where sC5b-9 is the Same Value as the Upper Limit of Normal or Less) | Nomacopan | 10 | Participants | ||
| Number of Participants With a Normalised Lactate Dehydrogenase (LDH) Value (Where LDH is the Same Value as the Upper Limit of Normal or Less) | Nomacopan | 2 | Participants | ||
| Normalisation of Lab Parameters | Nomacopan | 4 | Participants | ||
| Number of Participants Not Requiring a Platelet Transfusion (Transfusion Independence) for 28 Days or More. | Nomacopan | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nomacopan | 10 | |
| Overall Study | COMPLETED | Nomacopan | 6 | |
| Overall Study | NOT COMPLETED | Nomacopan | 4 |
Source ClinicalTrials.gov
Adverse events186
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 | Thrombocytopenia | Blood and lymphatic system disorders | Nomacopan - 1.7 mg/kg | 0 | 1 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nomacopan - 1.3 mg/kg | 0 | 3 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nomacopan - 1.0 mg/kg | 1 | 6 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nomacopan - 0.30 mg/kg | 3 | 10 | 24 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nomacopan - 0.45 mg/kg | 0 | 3 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nomacopan - 0.60 mg/kg | 0 | 0 | 0 |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Nomacopan - 1.7 mg/kg | 0 | 1 | 0 |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Nomacopan - 1.3 mg/kg | 0 | 3 | 0 |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Nomacopan - 1.0 mg/kg | 0 | 6 | 0 |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Nomacopan - 0.30 mg/kg | 5 | 10 | 16 |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nomacopan - 1.7 mg/kg | 0 | 1 |
| Total, all-cause mortality | Nomacopan - 1.3 mg/kg | 0 | 3 |
| Total, all-cause mortality | Nomacopan - 1.0 mg/kg | 0 | 6 |
| Total, all-cause mortality | Nomacopan - 0.30 mg/kg | 4 | 10 |
| Total, all-cause mortality | Nomacopan - 0.45 mg/kg | 0 | 3 |
| Total, all-cause mortality | Nomacopan - 0.60 mg/kg | 0 | 0 |
| Total, other adverse events | Nomacopan - 1.7 mg/kg | 0 | 1 |
| Total, other adverse events | Nomacopan - 1.3 mg/kg | 1 | 3 |
| Total, other adverse events | Nomacopan - 1.0 mg/kg | 1 | 6 |
| Total, other adverse events | Nomacopan - 0.30 mg/kg | 7 | 10 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04784455
GET https://conductscience.org/api/trials/v1/NCT04784455/events?page=2