Trial · NCT05629598
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| 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. |
| Secondary | Tmax | Day1-Day126/140 | Time to maximum observed plasma concentration of EPO. |
| Secondary | AUC 0-t | Day1-Day126/140 | Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration of EPO. |
| Secondary | AUC 0-∞ | Day1-Day126/140 | Area under the plasma concentration-time curve from time 0 to infinity. |
| Secondary | Emax | Day1-Day126/140 | Maximal effect concentriation |
| Secondary | Tmax of Emax | Day1-Day126/140 | Time to maximal effect concentriation |
| Secondary | AUE0-t | Day1-Day126/140 | Area under the plasma effect-concentriation curve from time 0 to the time of the last measurable concentration of EPO. |
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.
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GET https://conductscience.org/api/trials/v1/NCT05629598/registered