Trial · NCT07902726
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Iohexol Measured GFR | From baseline to the end of treatment at 16 weeks | The primary outcome of this study is the absolute change in measured GFR during each 2-week course of acetazolamide, while on background dapagliflozin therapy. GFR will be measured using plasma clearance of the iohexol contrast agent. The initial "dip" in GFR was selected as the primary outcome as it provides an early and measurable indicator of the treatment effect on kidney physiology. A transient reduction in GFR is a known physiological response to both acetazolamide and SGLT2i, reflecting their effects on hyperfiltration. Assessing this early change allows evaluation of the immediate physiological response to combination therapy but also acts as an indicator of the potential longer-term renal benefits. |
| Secondary | Measured GFR Recovery | From baseline to the end of treatment at 16 weeks | Measured GFR through iohexol clearance will be used to determine GFR recovery to baseline following each washout period. |
| Secondary | eGFR | From baseline to the end of treatment at 16 weeks | Measured using spot urine and FMV urine collection for serum creatinine, standardized per 1.73m2 body surface area. And estimated using CKD-EPI 2021 equation. |
| Secondary | Urine Albumin-to-Creatinine (UACR) | From baseline to the end of treatment at 16 weeks | UACR will be quantified by measuring albumin and creatinine excretion using the average of three FMV samples. |
| Secondary | Systolic Blood Pressure | From baseline to the end of treatment at 16 weeks. | Systolic blood pressure will be measured as per Hypertension Canada and assessed using an automated vital signs monitor (Connex Vital Signs Monitor, Welch Allyn). |
| Secondary | Diastolic Blood Pressure | From baseline to the end of treatment at 16 weeks | Diastolic blood pressure will be measured as per Hypertension Canada and assessed using an automated vital signs monitor (Connex Vital Signs Monitor, Welch Allyn). |
| Secondary | Change in Body Weight | From baseline to the end of treatment at 16 weeks | |
| Secondary | Mean Arterial Pressure | From baseline to the end of treatment at 16 weeks | Mean blood pressure will be measured as per Hypertension Canada and assessed using an automated vital signs monitor (Connex Vital Signs Monitor, Welch Allyn). |
| Secondary | Percent Fat Mass | From baseline to the end of treatment at 16 weeks | Bioimpedance analysis will be performed to determine percent body fat. |
| Secondary | Percent Extracellular Fluid | From baseline to the end of treatment at 16 weeks | Bioimpedance analysis will be performed to determine the percent extracellular fluid. |
| Secondary | Percent Total Body Water | From baseline to the end of treatment at 16 weeks | Bioimpedance analysis will be performed to determine percent total body water. |
| Other | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | From baseline to the end of treatment at 16 weeks | The side effects of acetazolamide and dapagliflozin have been well described and will be assessed at each study visit. Adverse events include acute kidney injury (AKI), volume depletion, hypokalemia, metabolic acidosis, hypoglycemia, and genitourinary infections. Frequent monitoring for adverse events has been integrated into the study design. All adverse events will be recorded on case report forms. |
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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