Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 11 of 11

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52	Baseline (Day 1, Week 0) and Week 28 to Week 52.	The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis.	g/dL	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With Hb Response During the First 24 Weeks of Treatment	Baseline (Day 1, Week 0) up to Week 24.	The Full Analysis Set (FAS) included all participants in the ITT analysis set who received at least 1 dose of IP and had baseline Hb and at least 1 post-dose Hb assessment. Participants from the FAS, with data available for analysis are presented.	Percentage of participants	NUMBER
SECONDARY	Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 in Participants With Baseline High Sensitivity C-Reactive Protein (hsCRP) Greater Than the Upper Limit of Normal (ULN)	Baseline (Day 1, Week 0) and Week 28 to Week 52.	The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. Only participants who consented to the use of donated biomarker samples and had baseline hsCRP \>ULN were included in the analysis.	g/dL	LEAST_SQUARES_MEAN
SECONDARY	Proportion of Total Time of Interpolated Hb Values Greater Than or Equal To 10 g/dL From Week 28 to Week 52	Week 28 up to Week 52.	The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. Participants without any Hb measurements from Week 28 were not included in the analysis.	proportion of total time	LEAST_SQUARES_MEAN
SECONDARY	Proportion of Total Time of Interpolated Hb Values Within the Interval of 10 to 12 g/dL From Week 28 to Week 52	Week 28 up to Week 52.	The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. Participants without any Hb measurements from Week 28 were not included in the analysis.	proportion of total time	LEAST_SQUARES_MEAN
SECONDARY	Mean Change in Low-Density Lipoprotein (LDL) Cholesterol From Baseline to Week 24	Baseline (Day 1, Week 0) and Week 24	The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis.	millimole per liter	LEAST_SQUARES_MEAN
SECONDARY	Time-To-First Instance of Receiving IV Iron, RBC Transfusion or Erythropoietin Analogue as Rescue Therapy	Baseline (Day1, Week 0) up to End of Study (EOS) visit (4 weeks after the treatment period) (or up to date of first rescue therapy), with treatment duration up to 4 years.	The on-treatment plus 28 days (OT+28) analysis set included all participants who received at least 1 dose of randomized IP, except for those excluded from analysis. Participants were censored 28 days after last intake of IP.	Events per 100 participant years	NUMBER
SECONDARY	Time-To-First Instance of Receiving a RBC Transfusion As Rescue Therapy	Baseline (Day1, Week 0) up to EOS visit (4 weeks after the treatment period) (or up to date of first RBC rescue therapy), with treatment duration up to 4 years.	The OT+28 analysis set included all participants who received at least 1 dose of randomized IP, except for those excluded from analysis. Participants were censored 28 days after last intake of IP.	Events per 100 participant years	NUMBER
SECONDARY	Mean Change From Baseline in Short Form 36 (SF-36) Vitality Sub-Score From Week 12 to Week 28	Baseline (Day 1, Week 0) and Week 12 to Week 28.	The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Annual Rate of eGFR Change From Baseline Prior to the Initiation of Dialysis or Kidney Transplant	Baseline (Day1, Week 0) up to EOS visit (4 weeks after the treatment period), with treatment duration up to 4 years.	The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis.	eGFR rate (mL/min/1.73m^2/years)	NUMBER
SECONDARY	Mean Change From Baseline in SF-36 Physical Functioning Sub-Score From Week 12 to Week 28	Baseline (Day 1, Week 0) and Week 12 to Week 28.	The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis.	scores on a scale	LEAST_SQUARES_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.

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GET https://conductscience.org/api/trials/v1/NCT02174627/outcomes

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