Trial · NCT03446612
Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF)
NCT03446612, Phase 2, Terminated, GlaxoSmithKline; results first posted 2021-07-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF). Trials, record NCT03446612. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03446612
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF)
- NCT number
- NCT03446612
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Anaemia
- Interventions
- Daprodustat, Darbepoetin alfa, Acetylcholine, Sodium nitroprusside, L-N-monomethyl arginine acetate (L-NMMA)
- First posted
- 2018-02-27
- Last updated
- 2024-03-27
- Other registries' IDs
- eudract:2017-002268-42
- Results first posted
- 2021-07-21
Source ClinicalTrials.gov
Registered outcomes53
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in FBF Ratio in Response to Acetylcholine (Day 1 to Day 42) | Day 1 to Day 42 | Venous occlusion plethysmography was used for FBF assessment. Acetylcholine (ACH) was infused intra-arterially at 7.5, 15 and 30 micrograms/minute (ug/min) each for 6 minutes per infusion. FBF ratio was defined as the ratio of a participant's treatment (infused) arm value divided by the non-treatment (non-infused) arm value. The overall ratio was determined by taking the participant's Day 42 FBF ratio and dividing by the Day 1 FBF ratio. |
| Secondary | Change in the Absolute FBF From Day 1 to Day 42 in Response to Acetylcholine | Day 1 to Day 42 | Venous occlusion plethysmography was used for FBF assessment. Acetylcholine was infused intra-arterially at 7.5, 15 and 30 ug/min each for 6 minutes per infusion. Measures were made in both arms concurrently. Change in the absolute FBF from Day 1 to Day 42 in response to acetylcholine is the difference between absolute value of FBF in infused arm on Day 1 and Day 42 in response to acetylcholine. |
| Secondary | Change in FBF Ratio in Response to Sodium Nitroprusside (Day 1 to Day 42) | Day 1 to Day 42 | Venous occlusion plethysmography was used for FBF assessment. Sodium nitroprusside was infused at 3 and 10 ug/min each for 6 minutes per infusion into the brachial artery of the test arm. FBF ratio was defined as the ratio of a participant's treatment (infused) arm value divided by the non-treatment (non-infused) arm value. The overall ratio was determined by taking the participant's Day 42 FBF ratio and dividing by the Day 1 FBF ratio. |
| Secondary | Change in the Absolute FBF From Day 1 to Day 42 in Response to Sodium Nitroprusside | Day 1 to Day 42 | Venous occlusion plethysmography was used for FBF assessment. Sodium nitroprusside was infused at 3 and 10 ug/min each for 6 minutes per infusion into the brachial artery of the test arm. Measures were made in both arms concurrently. Change in the absolute FBF from Day 1 to Day 42 in response to sodium nitroprusside is the difference between absolute value of FBF in infused arm on Day 1 and Day 42 in response to sodium nitroprusside. |
| Secondary | Change in FBF Ratio in Response to NG-monomethyl Arginine Acetate (L-NMMA) (Day 1 to Day 42) | Day 1 to Day 42 | Venous occlusion plethysmography was used for FBF assessment. Effects on basal nitric oxide synthesis was assessed using L-NMMA at doses of 2 and 8 micromoles per minute (umol/min) each infused for 6 minutes into the brachial artery of the test arm. FBF ratio was defined as the ratio of a participant's treatment (infused) arm value divided by the non-treatment (non-infused) arm value. The overall ratio was determined by taking the participant's Day 42 FBF ratio and dividing by the Day 1 FBF ratio. |
| Secondary | Change in the Absolute FBF From Day 1 to Day 42 in Response to L-NMMA | Day 1 to Day 42 | Venous occlusion plethysmography was used for FBF assessment. Effects on basal nitric oxide synthesis was assessed using L-NMMA at doses of 2 and 8 umol/min each infused for 6 minutes into the brachial artery of the test arm. Measures were made in both arms concurrently. Change in the absolute FBF from Day 1 to Day 42 in response to L-NMMA is the difference between absolute value of FBF in infused arm on Day 1 and Day 42 in response to L-NMMA. |
| Secondary | Change in FBF Ratio in Response to Acetylcholine at Day 42 Versus (vs) Day 1 in Participants Treated With Daprodustat | Day 1 and Day 42 | Venous occlusion plethysmography was used for FBF assessment. Acetylcholine was infused intra-arterially at 7.5, 15 and 30 ug/min each for 6 minutes per infusion. The Day 42 ratio was calculated by taking the participants Day 42 treatment (infused) arm and dividing by the Day 42 non-treatment (control) arm value. The Day 1 ratio was calculated by taking the participants Day 1 treatment (infused) arm and dividing by the Day 1 non-treatment (control) arm value. Change in FBF ratio from Day 1 to Day 42 was determined by taking the participants Day 42 ratio and dividing by the Day 1 ratio. |
| Secondary | Change in FBF Ratio in Response to Sodium Nitroprusside at Day 42 vs Day 1 in Participants Treated With Daprodustat | Day 1 and Day 42 | Venous occlusion plethysmography was used for FBF assessment. Sodium nitroprusside was infused at 3 and 10 ug/min each for 6 minutes per infusion into the brachial artery of the test arm. The Day 42 ratio was calculated by taking the participants Day 42 treatment (infused) arm and dividing by the Day 42 non-treatment (control) arm value. The Day 1 ratio was calculated by taking the participants Day 1 treatment (infused) arm and dividing by the Day 1 non-treatment (control) arm value. Change in FBF ratio from Day 1 to Day 42 was determined by taking the participants Day 42 ratio and dividing by the Day 1 ratio. |
| Secondary | Change in FBF Ratio in Response to L-NMMA at Day 42 vs Day 1 in Participants Treated With Daprodustat | Day 1 and Day 42 | Venous occlusion plethysmography was used for FBF assessment. Effects on basal nitric oxide synthesis was assessed using L-NMMA at doses of 2 and 8 umol/min each infused for 6 minutes into the brachial artery of the test arm. The Day 42 ratio was calculated by taking the participants Day 42 treatment (infused) arm and dividing by the Day 42 non-treatment (control) arm value. The Day 1 ratio was calculated by taking the participants Day 1 treatment (infused) arm and dividing by the Day 1 non-treatment (control) arm value. Change in FBF ratio from Day 1 to Day 42 was determined by taking the participants Day 42 ratio and dividing by the Day 1 ratio. |
| Secondary | Change in FBF Ratio in Response to Acetylcholine at Day 42 vs Day 1 in Participants Treated With Darbepoetin Alfa | Day 1 and Day 42 | Venous occlusion plethysmography was used for FBF assessment. Acetylcholine was infused intra-arterially at 7.5, 15 and 30 ug/min each for 6 minutes per infusion. The Day 42 ratio was calculated by taking the participants Day 42 treatment (infused) arm and dividing by the Day 42 non-treatment (control) arm value. The Day 1 ratio was calculated by taking the participants Day 1 treatment (infused) arm and dividing by the Day 1 non-treatment (control) arm value. Change in FBF ratio from Day 1 to Day 42 was determined by taking the participants Day 42 ratio and dividing by the Day 1 ratio. |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 registered outcomesOutcomes53
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in FBF Ratio in Response to Acetylcholine (Day 1 to Day 42) | Day 1 to Day 42 | Pharmacodynamic Per-Protocol (PDPP) population included all randomized participants who provided pharmacodynamic (PD) data at Day 1 and Day 42. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Ratio | MEAN |
| SECONDARY | Change in the Absolute FBF From Day 1 to Day 42 in Response to Acetylcholine | Day 1 to Day 42 | PDPP Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | ug/min | MEAN |
| SECONDARY | Change in FBF Ratio in Response to Sodium Nitroprusside (Day 1 to Day 42) | Day 1 to Day 42 | PDPP Population. Only those participants with data available at the specified data points were analyzed. | Ratio | MEAN |
| SECONDARY | Change in the Absolute FBF From Day 1 to Day 42 in Response to Sodium Nitroprusside | Day 1 to Day 42 | PDPP Population. Only those participants with data available at the specified data points were analyzed. | ug/min | MEAN |
| SECONDARY | Change in FBF Ratio in Response to NG-monomethyl Arginine Acetate (L-NMMA) (Day 1 to Day 42) | Day 1 to Day 42 | PDPP Population. Only those participants with data available at the specified data points were analyzed. | Ratio | MEAN |
| SECONDARY | Change in the Absolute FBF From Day 1 to Day 42 in Response to L-NMMA | Day 1 to Day 42 | PDPP Population. Only those participants with data available at the specified data points were analyzed. | umol/min | MEAN |
| SECONDARY | Change in FBF Ratio in Response to Acetylcholine at Day 42 Versus (vs) Day 1 in Participants Treated With Daprodustat | Day 1 and Day 42 | PDPP Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Ratio | MEAN |
| SECONDARY | Change in FBF Ratio in Response to Sodium Nitroprusside at Day 42 vs Day 1 in Participants Treated With Daprodustat | Day 1 and Day 42 | PDPP Population. Only those participants with data available at the specified data points were analyzed. | Ratio | MEAN |
| SECONDARY | Change in FBF Ratio in Response to L-NMMA at Day 42 vs Day 1 in Participants Treated With Daprodustat | Day 1 and Day 42 | PDPP Population. Only those participants with data available at the specified data points were analyzed. | Ratio | MEAN |
| SECONDARY | Change in FBF Ratio in Response to Acetylcholine at Day 42 vs Day 1 in Participants Treated With Darbepoetin Alfa | Day 1 and Day 42 | PDPP Population | Ratio | MEAN |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 outcomesResults by group500
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in FBF Ratio in Response to Acetylcholine (Day 1 to Day 42) | Daprodustat | ACH 7.5 ug/min, n=2, 2 | 1.1304 | Standard Deviation 0.30030 | Ratio |
| Change in FBF Ratio in Response to Acetylcholine (Day 1 to Day 42) | Darbepoetin Alfa | ACH 7.5 ug/min, n=2, 2 | 0.4351 | Standard Deviation 0.17032 | Ratio |
| Change in FBF Ratio in Response to Acetylcholine (Day 1 to Day 42) | Daprodustat | ACH 15 ug/min, n=1, 2 | 0.7866 | Standard Deviation NA | Ratio |
| Change in FBF Ratio in Response to Acetylcholine (Day 1 to Day 42) | Darbepoetin Alfa | ACH 15 ug/min, n=1, 2 | 0.6183 | Standard Deviation 0.00435 | Ratio |
| Change in FBF Ratio in Response to Acetylcholine (Day 1 to Day 42) | Daprodustat | ACH 30 ug/min, n=1, 2 | 1.1328 | Standard Deviation NA | Ratio |
| Change in FBF Ratio in Response to Acetylcholine (Day 1 to Day 42) | Darbepoetin Alfa | ACH 30 ug/min, n=1, 2 | 0.8090 | Standard Deviation 0.28395 | Ratio |
| Change in the Absolute FBF From Day 1 to Day 42 in Response to Acetylcholine | Daprodustat | 7.5 ug/min, n=2, 2 | 8.3180 | Standard Deviation 4.50592 | ug/min |
| Change in the Absolute FBF From Day 1 to Day 42 in Response to Acetylcholine | Darbepoetin Alfa | 7.5 ug/min, n=2, 2 | -6.0360 | Standard Deviation 3.09976 | ug/min |
| Change in the Absolute FBF From Day 1 to Day 42 in Response to Acetylcholine | Daprodustat | 15 ug/min, n=1, 2 | -4.6374 | Standard Deviation NA | ug/min |
| Change in the Absolute FBF From Day 1 to Day 42 in Response to Acetylcholine | Darbepoetin Alfa | 15 ug/min, n=1, 2 | -8.8299 | Standard Deviation 9.98143 | ug/min |
1 to 10 of 500Source ClinicalTrials.gov
See all 500 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Daprodustat | 2 | |
| Overall Study | STARTED | Darbepoetin Alfa | 3 | |
| Overall Study | COMPLETED | Daprodustat | 2 | |
| Overall Study | COMPLETED | Darbepoetin Alfa | 2 | |
| Overall Study | NOT COMPLETED | Daprodustat | 0 | |
| Overall Study | NOT COMPLETED | Darbepoetin Alfa | 1 |
Source ClinicalTrials.gov
Adverse events14
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 | Faeces soft | Gastrointestinal disorders | Daprodustat | 0 | 2 | 0 |
| other | Faeces soft | Gastrointestinal disorders | Darbepoetin Alfa | 1 | 3 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Daprodustat | 0 | 2 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Darbepoetin Alfa | 1 | 3 | 1 |
| other | Gout | Metabolism and nutrition disorders | Daprodustat | 0 | 2 | 0 |
| other | Gout | Metabolism and nutrition disorders | Darbepoetin Alfa | 1 | 3 | 1 |
| other | Bilateral foot discomfort secondary to Gout | Metabolism and nutrition disorders | Daprodustat | 0 | 2 | 0 |
| other | Bilateral foot discomfort secondary to Gout | Metabolism and nutrition disorders | Darbepoetin Alfa | 1 | 3 | 1 |
| other | Swollen right foot secondary to Gout | Metabolism and nutrition disorders | Daprodustat | 0 | 2 | 0 |
| other | Swollen right foot secondary to Gout | Metabolism and nutrition disorders | Darbepoetin Alfa | 1 | 3 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daprodustat | 0 | 2 |
| Total, all-cause mortality | Darbepoetin Alfa | 0 | 3 |
| Total, other adverse events | Daprodustat | 0 | 2 |
| Total, other adverse events | Darbepoetin Alfa | 1 | 3 |
| Total, serious adverse events | Daprodustat | 0 | 2 |
| Total, serious adverse events | Darbepoetin Alfa | 0 | 3 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36005278 | DERIVED |
Source PubMed
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 |
|---|---|
| Daprodustat vs Darbepoetin Alfa: Number of Participants Discontinuing the Randomized Study Treatment | Trial comparisons |
| Daprodustat vs Darbepoetin Alfa: Number of Participants With Any AE of Special Interest (AESI) | Trial comparisons |
| Daprodustat vs Darbepoetin Alfa: deaths from any cause | Trial comparisons |
| Daprodustat vs Darbepoetin Alfa: 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.
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