Trial · NCT05682326
Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)
NCT05682326, Phase 3, Completed, GlaxoSmithKline; results first posted 2025-11-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P). Trials, record NCT05682326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05682326
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)
- NCT number
- NCT05682326
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Anaemia
- Interventions
- Daprodustat
- First posted
- 2023-01-12
- Last updated
- 2025-11-10
- Results first posted
- 2025-11-10
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 56 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other situations as per medical and scientific judgement of the Investigator. |
| Primary | Number of Participants With Adverse Event of Special Interests (AESIs) | Up to 56 weeks | AESIs are AEs of scientific interest specific to the drug class as per investigator assessment. AESI included: Death, Myocardial Infarction (MI), stroke, Heart Failure (HF), thromboembolic events, thrombosis of vascular access, Thrombosis and/or tissue ischemia secondary to excessive erythropoiesis, New diagnosis of hypertension or worsening of existing hypertension, Cancer related mortality and tumor progression and recurrence, Esophageal and gastric erosions. Number of participants with any AESIs have been presented. |
| Primary | Number of Participants With AEs Leading to Study Intervention Discontinuation | Up to 52 weeks | All AEs leading to study intervention discontinuation were collected. Number of participants with any AEs leading to study intervention discontinuation have been presented |
| Secondary | Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Secondary | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected to analyze the hematology parameter: Reticulocytes/Erythrocytes. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Secondary | Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected to analyze the hematology parameter: Erythrocytes. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Secondary | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet count. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Secondary | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Secondary | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
| Secondary | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood samples were collected to analyze the clinical chemistry parameters: Calcium, Potassium, Sodium and BUN. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 56 weeks | The analysis was performed on the Safety Set that included all participants who were enrolled and took at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Event of Special Interests (AESIs) | Up to 56 weeks | Safety Set | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With AEs Leading to Study Intervention Discontinuation | Up to 52 weeks | Safety Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Percentage of red blood cells in blood | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Ratio of Reticulocytes to Erythrocytes | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Trillion cells per Liter (10^12 cells/L) | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Giga cells per Liter (10^9 cells/L) | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Femtoliter (fL) | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Picogram (pg) | MEAN |
| SECONDARY | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | millimoles per liter (mmol/L) | MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group943
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants Requiring Dialysis (D) | Any AEs | 2 | Participants | |
| Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants Not Yet Requiring Dialysis (ND) | Any AEs | 2 | Participants | |
| Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants Requiring Dialysis (D) | Any SAEs | 1 | Participants | |
| Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants Not Yet Requiring Dialysis (ND) | Any SAEs | 0 | Participants | |
| Number of Participants With Adverse Event of Special Interests (AESIs) | Participants Requiring Dialysis (D) | 0 | Participants | ||
| Number of Participants With Adverse Event of Special Interests (AESIs) | Participants Not Yet Requiring Dialysis (ND) | 0 | Participants | ||
| Number of Participants With AEs Leading to Study Intervention Discontinuation | Participants Requiring Dialysis (D) | 0 | Participants | ||
| Number of Participants With AEs Leading to Study Intervention Discontinuation | Participants Not Yet Requiring Dialysis (ND) | 0 | Participants | ||
| Change From Baseline in Hematology Parameter: Hematocrit | Participants Requiring Dialysis (D) | Week 4 | 0.0160 | Standard Deviation NA | Percentage of red blood cells in blood |
| Change From Baseline in Hematology Parameter: Hematocrit | Participants Not Yet Requiring Dialysis (ND) | Week 4 | 0.0030 | Standard Deviation 0.03818 | Percentage of red blood cells in blood |
1 to 10 of 943Source ClinicalTrials.gov
See all 943 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants Requiring Dialysis (D) | 2 | |
| Overall Study | STARTED | Participants Not Yet Requiring Dialysis (ND) | 2 | |
| Overall Study | COMPLETED | Participants Requiring Dialysis (D) | 1 | |
| Overall Study | COMPLETED | Participants Not Yet Requiring Dialysis (ND) | 2 | |
| Overall Study | NOT COMPLETED | Participants Requiring Dialysis (D) | 1 | |
| Overall Study | NOT COMPLETED | Participants Not Yet Requiring Dialysis (ND) | 0 |
Source ClinicalTrials.gov
Adverse events16
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 | Nasopharyngitis | Infections and infestations | Participants Requiring Dialysis (D) | 0 | 2 | 0 |
| other | Nasopharyngitis | Infections and infestations | Participants Not Yet Requiring Dialysis (ND) | 1 | 2 | 2 |
| other | Foot fracture | Injury, poisoning and procedural complications | Participants Requiring Dialysis (D) | 0 | 2 | 0 |
| other | Foot fracture | Injury, poisoning and procedural complications | Participants Not Yet Requiring Dialysis (ND) | 1 | 2 | 1 |
| other | COVID-19 | Infections and infestations | Participants Requiring Dialysis (D) | 0 | 2 | 0 |
| other | COVID-19 | Infections and infestations | Participants Not Yet Requiring Dialysis (ND) | 1 | 2 | 1 |
| other | Hypertension | Vascular disorders | Participants Requiring Dialysis (D) | 1 | 2 | 1 |
| other | Hypertension | Vascular disorders | Participants Not Yet Requiring Dialysis (ND) | 0 | 2 | 0 |
| other | Serum ferritin increased | Investigations | Participants Requiring Dialysis (D) | 1 | 2 | 1 |
| other | Serum ferritin increased | Investigations | Participants Not Yet Requiring Dialysis (ND) | 0 | 2 | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants Requiring Dialysis (D) | 0 | 2 |
| Total, all-cause mortality | Participants Not Yet Requiring Dialysis (ND) | 0 | 2 |
| Total, other adverse events | Participants Requiring Dialysis (D) | 2 | 2 |
| Total, other adverse events | Participants Not Yet Requiring Dialysis (ND) | 2 | 2 |
| Total, serious adverse events | Participants Requiring Dialysis (D) | 1 | 2 |
| Total, serious adverse events | Participants Not Yet Requiring Dialysis (ND) | 0 | 2 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Participants Requiring Dialysis (D) vs Participants Not Yet Requiring Dialysis (ND): Number of Participants With Adverse Event of Special Interests (AESIs) | Trial comparisons |
| Participants Requiring Dialysis (D) vs Participants Not Yet Requiring Dialysis (ND): deaths from any cause | Trial comparisons |
| Participants Requiring Dialysis (D) vs Participants Not Yet Requiring Dialysis (ND): Number of Participants With AEs Leading to Study Intervention Discontinuation | Trial comparisons |
| Participants Requiring Dialysis (D) vs Participants Not Yet Requiring Dialysis (ND): serious adverse events | Trial comparisons |
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/NCT05682326
GET https://conductscience.org/api/trials/v1/NCT05682326/registered?page=2