Trial · NCT06217302
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | eGFR at the end of the wash-out period following the treatment period | End of the 2-month wash-out period following the 3-year treatment period (weeks 162 and 164) | eGFR at the end of the 8-week drug washout period following the 3-year treatment period, estimated from Central Lab serum creatinine and cystatin C using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation and adjusted by its baseline value. Baseline and end-of-washout eGFRs will be considered as the average of two eGFR values taken on two separate days before randomization (V2 and V4) and after the washout (V18 and V19), respectively. |
| Secondary | Time to ≥40% eGFR decline from baseline, kidney failure , or death from renal causes | Up to the end of the 2-month wash-out period following the 3-year treatment period (week 0 to 164) | Time from randomization to 1. sustained ≥40% eGFR decline (based on eGFR estimated from serum creatinine and cystatin C using the 2021 CKD-EPI equation) confirmed after 30 days; 2. kidney failure, defined by eGFR ≤10ml/min/ 1.73m2 confirmed after 30 days or occurring within 30 days prior to death, or initiation of maintenance kidney replacement therapy; or 3. death from kidney-related causes. If an eGFR value meeting the above criteria is observed at the last study visit or immediately before a participant is lost to follow-up or withdraws from the study, no confirmation of this value will be necessary. |
| Other | eGFR at the end of the 3-yr treatment period | End of the 3-year treatment period (week 156) | eGFR at the end of the 3-yr treatment period (before the washout period) adjusted for the baseline value |
| Other | Time to fatal or non-fatal cardiovascular disease (CVD) events | Up to the end of the 2-month wash-out period following the 3-year treatment period (week 0 to 164) | Time to fatal or non-fatal CVD events (CV death, non-fatal myocardial infarction, non-fatal stroke, or coronary, carotid, or peripheral revascularization procedures) |
| Other | Time to hospitalization or urgent visit for heart failure or CV death | Up to the end of the 2-month wash-out period following the 3-year treatment period (week 0 to 164) | Time to hospitalization or urgent visit for heart failure or death for cardiovascular causes |
| Other | Time to hospitalization for heart failure | Up to the end of the 2-month wash-out period following the 3-year treatment period (week 0 to 164) | Time to hospitalization for heart failure |
| Other | B-type natriuretic peptide (NTproBNP) serum levels at the end of the drug washout | End of the 2-month wash-out period following the 3-year treatment period (week 164) | Serum levels of NTproBNP at the end of the 8-week drug washout, adjusted for its baseline value |
| Other | High-sensitivity cardiac troponin (hs-cTnT) serum levels at the end of the drug washout | End of the 2-month wash-out period following the 3-year treatment period (week 164) | Serum levels of hs-cTnT at the end of the 8-week drug washout, adjusted for its baseline value |
| Other | NTproBNP serum levels at the end of the treatment period | End of the 3-year treatment period (week 156) | Serum levels of B-type natriuretic peptide (NTproBNP) at the end of the 3-year treatment period, adjusted for its baseline value |
| Other | hs-cTnT serum levels at the end of the treatment period | End of the 3-year treatment period (week 156) | Serum levels of high-sensitivity cardiac troponin (hs-cTnT ) at the end of the 3-year treatment period, adjusted for its baseline value |
| Other | Mean blood HbA1c levels during the treatment period | Weeks 0, 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period) | Mean HbA1c during the 3-year treatment period |
| Other | Mean blood glucose levels during the treatment period | Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period) | Mean blood glucose from continuous glucose monitoring during the 3-year treatment period |
| Other | Mean GMI during the treatment period | Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period) | Mean glucose management indicator (GMI) from continuous glucose monitoring during the 3-year treatment period |
| Other | Mean time in range (TIR) during the treatment period | Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period) | Mean time with blood glucose in the 70 to 180 mg /dl range from continuous glucose monitoring during the 3-year treatment period |
| Other | Mean time below range 70 (TBR70) during the treatment period | Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period) | Mean time with blood glucose below 70 mg/dl from continuous glucose monitoring during the 3-year treatment period |
| Other | Mean time below range 54 (TBR54) during the treatment period | Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period) | Mean time with blood glucose below 54 mg/dl from continuous glucose monitoring during the 3-year treatment period |
| Other | Mean time above range 180 (TAR180) during the treatment period | Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period) | Mean time with blood glucose above 180 mg/dl from continuous glucose monitoring during the 3-year treatment period |
| Other | Mean time above range 250 (TAR250) during the treatment period | Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period) | Mean time with blood glucose above 250 mg/dl from continuous glucose monitoring during the 3-year treatment period |
| Other | Mean Glucose CV during the treatment period | Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period) | Mean blood glucose coefficient of variation (CV) from continuous glucose monitoring during the 3-year treatment period |
| Other | Mean MAGE during the treatment period | Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period) | Mean amplitude of glycemic excursions (MAGE) from continuous glucose monitoring during the 3-year treatment period |
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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