Trial · NCT04925661
HEC53856 Phase Ib Study in Patients With Non-dialysis Renal Anemia
NCT04925661, Phase 1, Completed, Sunshine Lake Pharma Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. HEC53856 Phase Ib Study in Patients With Non-dialysis Renal Anemia. Trials, record NCT04925661. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04925661
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- HEC53856 Phase Ib Study in Patients With Non-dialysis Renal Anemia
- NCT number
- NCT04925661
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 40 participants, actual
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Conditions
- Chronic Kidney Diseases, Renal Anemia
- Interventions
- HEC53856, Roxadustat, Placebo
- First posted
- 2021-06-14
- Last updated
- 2025-05-15
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events | Through study completion, an average of 12 weeks. | To assess the safety and tolerability of therapy by incidence of treatment-emergent adverse events after multiple doses of HEC53856 capsule |
| Secondary | AUC0-t | Day 1(Dosing) until Day 55 after single and multiple drug dosing. | Area under the concentration versus time curve (AUC) from time zero to the time of the last quantifiable concentration |
| Secondary | Cmax | Day 1(Dosing) until Day 55 after single and multiple drug dosing. | Maximum observed plasma concentration |
| Secondary | Tmax | Day 1(Dosing) until Day 55 after single and multiple drug dosing. | Time of the maximum observed plasma concentration |
| Secondary | T½ | Day 1(Dosing) until Day 55 after single and multiple drug dosing. | Apparent terminal elimination half-life |
| Secondary | Vz/F | Day 1(Dosing) until Day 55 after single and multiple drug dosing. | Apparent volume of distribution |
| Secondary | Changes in mean hemoglobin | week 10 | Changes in mean hemoglobin (Hb) relative to baseline during weeks 8 and 10. |
| Secondary | Hemoglobin response | week 10 | Percentage of subjects who met the hemoglobin response after dosing |
| Secondary | E-AUC0-t | Day 1(Dosing) until Day 55 after single and multiple drug dosing. | Area under the EPO concentration versus time curve (AUC) from time zero to the time of the last quantifiable concentration |
| Secondary | Emax | Day 1(Dosing) until Day 55 after single and multiple drug dosing. | Maximum observed EPO concentration |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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
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/NCT04925661
GET https://conductscience.org/api/trials/v1/NCT04925661/registered