Trial · NCT07045155
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The change in mean hemoglobin (Hb) levels from baseline at weeks 12 to 16 of treatment in the three groups. | During weeks 12 to 16 of the study treatment | Primary efficacy endpoints |
| Secondary | The proportion of participants in the three groups with mean Hb levels ≥100 g/L and ≤120 g/L at weeks 12 to 16 and weeks 20 to 24 of treatment. | During weeks 12 to 16 and weeks 20 to 24 of the study treatment | secondary efficacy endpoints |
| Secondary | The proportion of participants in the three groups with mean Hb levels ≥110 g/L and ≤130 g/L at weeks 12 to 16 and weeks 20 to 24 of treatment. | During weeks 12 to 16 and weeks 20 to 24 of the study treatment | secondary efficacy endpoints |
| Secondary | The proportion of participants in the three groups with mean Hb levels ≥100 g/L at weeks 12 to 16 and weeks 20 to 24 of treatment. | During weeks 12 to 16 and weeks 20 to 24 of the study treatment | secondary efficacy endpoints |
| Secondary | The proportion of participants in the three groups with mean Hb levels ≥110 g/L at weeks 12 and 24 of treatment. | at weeks 12 and 24 of treatment. | secondary efficacy endpoints |
| Secondary | The median time to first reach the target Hb level (110-130 g/L) during the treatment period in the three groups. | up to 24 weeks | secondary efficacy endpoints |
| Secondary | The absolute values of hemoglobin (Hb) levels during the treatment period in the three groups. | up to 24 weeks | secondary efficacy endpoints |
| Secondary | The absolute values of changes in hemoglobin (Hb) levels from baseline during the treatment period in the three groups. | up to 24 weeks | secondary efficacy endpoints |
| Secondary | The absolute values of red blood cell (RBC) count levels during the treatment period in the three groups. | up to 24 weeks | secondary efficacy endpoints |
| Secondary | The absolute values of hematocrit levels during the treatment period in the three groups. | up to 24 weeks | secondary efficacy endpoints |
| Secondary | The dosage of the study drug used between each pair of consecutive follow-up visits during the treatment period in the three groups. | up to 24 weeks | secondary efficacy endpoints |
| Secondary | The average dosage of the study drug used by participants with Hb levels within the target range (100 g/L ≤ Hb ≤ 120 g/L) at each follow-up visit during the treatment period in the three groups. | up to 24 weeks | secondary efficacy endpoints |
| Secondary | The average dosage of the study drug used by participants with Hb levels within the target range (110 g/L ≤ Hb ≤ 130 g/L) at each follow-up visit during the treatment period in the three groups. | up to 24 weeks | secondary efficacy endpoints |
| Secondary | The total number of dosage adjustments at weeks 12 and 24 in the three groups. | At weeks 12 and 16 of the study treatment | secondary efficacy endpoints |
| Secondary | The rate of Hb increase during the first 4 weeks and first 8 weeks of treatment in the three groups. | during the first 4 weeks and first 8 weeks of treatment in the three groups. | secondary efficacy endpoints |
| Secondary | The proportion of participants receiving rescue therapy during the treatment period in the three groups. | up to 24 weeks | secondary efficacy endpoints |
| Other | Artificial intelligence (AI)-predicted rational dosing regimens for medications. | through study completion, an average of 1 year | Upon completion of the experiment and collection of relevant data from the participants, we will employ artificial intelligence and machine learning techniques to model and train our database. This process will involve the development of an artificial intelligence-based predictive model. This model will be capable of forecasting individual patients' needs for peginesatide to maintain hemoglobin (Hb) levels within the target range, as well as predicting monthly dose adjustments for peginesatide. Ultimately, this approach aims to optimize anemia management in patients with chronic kidney disease (CKD). |
| Other | The change in carbamylated EPO levels from baseline at week 16 of treatment in the three groups. | The change from baseline data at week 16 of treatment | Exploratory endpoints |
| Other | Subgroup analysis based on different baseline characteristics | up to 24 weeks | Exploratory endpoints |
| Other | Thromboembolic events: It is necessary to distinguish whether the thromboembolic events are related to blood vessels or catheters, and to identify whether they are caused by thrombus formation. | up to 24 weeks | Safety endpoints |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07045155/registered