Trial · NCT03819153
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope) | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | (mL/min/1.73 m^2)/year | MEAN |
| SECONDARY | Number of Participants From Time of Randomization to Occurrence of Onset of Persistent ≥50% Reduction in eGFR (CKD-EPI) | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants From Time of Randomization to Occurrence of Onset of Persistent eGFR (CKD-EPI) <15mL/Min/1.73m^2 | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants From Time of Randomization to Occurrence of Initiation of Chronic Renal Replacement Therapy | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants From Time of Randomization to Occurrence of Renal Death | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants From Time of Randomization to Occurrence of CV Death | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Annual Rate of Change in eGFR (Chronic Kidney Disease CKD-EPI) (Chronic eGFR Slope) | Week 12, Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | mL/min/1.73 m^2 | MEAN |
| SECONDARY | Change From Baseline in eGFR (CKD-EPI) at Week 12 | Baseline (Week 0), Week 12 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | mL/min/1.73m^2 | MEAN |
| SECONDARY | Change From Baseline in eGFR (Cystatin C CKD-EPI) at Week 104 | Baseline (Week 0), Week 104 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | mL/min/1.73m^2 | MEAN |
| SECONDARY | Change From Baseline in Urinary Albumin-to-creatinine Ratio (UACR) at Week 104: Ratio to Baseline | Baseline (Week 0), Week 104 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants From Time of Randomization to Time to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Acute Myocardial Infarction (Non Fatal); Non-fatal Stroke; and CV Death | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants From Time of Randomization to Time to Occurrence of All-cause Death | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Myocardial Infarction | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Stroke | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants From Time of Randomization to Time to First Occurrence of Major Adverse Limb Events (MALE): Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Body Weight at Week 104 | Baeline (Week 0), Week 104 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | Kilograms | MEAN |
| SECONDARY | Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 104 | Baseline (Week 0), Week 104 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | Percentage of HbA1c | MEAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure at Week 104 | Baseline (Week 0), Week 104 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | Millimeters of mercury | 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.
For software
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