Trial · NCT05629598
A Study of PEG-EPO Injection (CHO Cells) for Maintenance Therapy of Patients With Renal Anemia .
NCT05629598, Phase 2, Unknown, Angde Biotech Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of PEG-EPO Injection (CHO Cells) for Maintenance Therapy of Patients With Renal Anemia . Trials, record NCT05629598. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05629598
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of PEG-EPO Injection (CHO Cells) for Maintenance Therapy of Patients With Renal Anemia .
- NCT number
- NCT05629598
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 150 participants, estimated
- Lead sponsor
- Angde Biotech Pharmaceutical Co., Ltd.
- Conditions
- Renal Anemia
- Interventions
- Recombinant human erythropoietin injection, Human erythropoietin injection
- First posted
- 2022-11-29
- Last updated
- 2022-11-29
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of mean hemoglobin compared to baseline during fixed treatment | Day1-Day42 | Change of mean hemoglobin (Hb) content from baseline during fixed treatment (fixed treatment：week 1 to week 6) |
| Primary | Change of mean hemoglobin during dose adjustment period | Day85-Day126 | Change of mean hemoglobin compared to baseline from week 13 to 18 during dose adjustment period (dose adjustment period: week 7 to week 18/week 20). |
| Secondary | Proportion of patients with hemoglobin keeping within the target range | Day1-Day42、Day85-Day126 | Proportion of patients with hemoglobin keeping within the target range (target range: the variation from baseline Hb is within ±10g/L, and HB is in the range of 100-130g/L) during treatment period (fixed treatment, week 13 to 18 during dose adjustment period). |
| Secondary | Reticulocyte count, Hematocrit, Erythrocyte count | Day1-Day42、Day85-Day126 | Changes of mean values of other evaluation indexes (including HCT, RET, RBC) between baseline and different stages of treatment (fixed treatment period, week 13 to 18 of dose adjustment period). |
| Secondary | Proportion of patients receiving red blood cell transfusion and number of transfusions during the trial. | Day1-Day126/140 | |
| Secondary | Number of iron deficiency, number of patients and proportion of patients with iron deficiency during the trial | Day1-Day126/140 | Iron deficiency was defined as SF≤100μg/L and TSAT≤20% in peritoneal dialysis subjects; SF≤200μg/L and TSAT≤20% in hemodialysis subjects. |
| Secondary | The number and proportion of patients with dose adjustments during the trial | Day1-Day126/140 | |
| Secondary | Anti-drug antibody | 1,5, 9, 13, 17 weeks (before administration) and 28±2 days after the last administration (A2/B2group ,A1/B1 patients with intensive blood collection) or 14±2 days after the last administration (A1/B1 patients with sparse blood collection) | The incidence of ADA and Nab |
| Secondary | Adverse events | Day1-Day126/140 | Any adverse event that occurred during the clinical trials of all patients. |
| Secondary | Cmax | Day1-Day126/140 | Maximum observed plasma concentration of EPO. |
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/NCT05629598
GET https://conductscience.org/api/trials/v1/NCT05629598/registered