Trial · NCT03400033
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Hemoglobin Levels Over the Evaluation Period (Week 28 to Week 52) | Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52) | All Randomized (Intent-to-treat \[ITT\]) Population comprised of all randomized participants. Any participant who received a treatment randomization number was considered to have been randomized. | Grams per deciliter (g/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Average Monthly On-treatment Intravenous (IV) Iron Dose Per Participant | Day 1 to Week 52 | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed. | Milligrams | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Hemoglobin Levels at Week 52 | Baseline (Pre-dose on Day 1) and Week 52 | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed. | Grams per deciliter | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52) | Week 28 to Week 52 | All Randomized (ITT) Population. Only those participants with at least one evaluable hemoglobin value during the evaluation period were analyzed. | Percentage of days | MEDIAN |
| SECONDARY | Number of Hemoglobin Responders in the Hemoglobin Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52) | Week 28 to Week 52 | All Randomized (ITT) Population. Only those participants with at least one evaluable hemoglobin value during the evaluation period were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Permanently Stopping Study Treatment Due to Meeting Rescue Criteria | Up to Week 52 | All Randomized (ITT) Population | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP) at Week 52 | Baseline (Week -4 ) and Week 52 | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed. | Millimeter of mercury (mmHg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SBP, DBP and MAP at End of Treatment | Baseline (Week -4) and end of treatment (last on-treatment value until Week 52) | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed. | Millimeter of mercury (mmHg) | MEAN |
| SECONDARY | Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years | Up to 52 weeks | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed. | Events per 100 participant years | NUMBER |
| SECONDARY | Number of Participants With at Least One BP Exacerbation Event During the Study | Up to 52 weeks | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline at Weeks 8, 12, 28 and 52 in Patient Global Impression of Severity (PGI-S) | Baseline (Pre-dose on Day 1) and Weeks 8, 12, 28, 52 | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed (represented as n=X in the category titles). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Pre-dose Trough Concentration (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13) | Pre-dose on Day 1; Pre-dose and at 0.5, 1, 2, 3 hours post-dose on any one post-Baseline visit day between Week 8 and Week 52 | Pharmacokinetic Population comprised of all randomized participants for whom a post-Baseline pharmacokinetic sample was obtained and analyzed. Only those participants with data available at specified time points were analyzed (represented as n=X in the category titles). | Nanograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13) | Pre-dose on Day 1; Pre-dose and at 0.5, 1, 2, 3 hours post-dose on any one post-Baseline visit day between Week 8 and Week 52 | Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed (represented as n=X in the category titles). | Nanograms per milliliter | GEOMETRIC_MEAN |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03400033/outcomes