HYDROchlorothiazide versus placebo to PROTECT polycystic kidney disease patients and improve their quality of life: study protocol and rationale for the HYDRO-PROTECT randomized controlled trial
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View abstract on PubMed
Summary
This summary is machine-generated.This study investigates if adding hydrochlorothiazide (HCT) to tolvaptan improves kidney function in autosomal dominant polycystic kidney disease (ADPKD) patients. The research aims to enhance tolvaptan
Area Of Science
- Nephrology
- Clinical Pharmacology
- Genetics and Hereditary Diseases
Background
- Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive cyst formation and kidney function loss.
- Vasopressin 2 receptor antagonists (V2RA), such as tolvaptan, are the sole renoprotective agents for rapidly progressive ADPKD but are limited by aquaretic side effects.
- Preliminary data suggest hydrochlorothiazide (HCT) may mitigate tolvaptan's side effects and enhance its efficacy.
Purpose Of The Study
- To evaluate the long-term impact of co-administering hydrochlorothiazide (HCT) with tolvaptan on the efficacy and tolerability in ADPKD patients.
- To assess whether HCT improves the renoprotective effects of tolvaptan by examining the rate of kidney function decline.
- To determine if HCT enhances tolvaptan's tolerability by analyzing aquaresis and patient quality of life.
Main Methods
- The HYDRO-PROTECT study is a multicenter, double-blind, placebo-controlled, randomized clinical trial.
- 300 patients with rapidly progressive ADPKD (eGFR > 25 mL/min/1.73 m<sup>2</sup>) on stable tolvaptan treatment will be enrolled.
- Participants will be randomized to receive either daily oral HCT 25 mg or a placebo for 156 weeks, alongside standard care.
Main Results
- The primary outcome is the difference in the rate of kidney function decline (eGFR slope) between the HCT and placebo groups.
- Secondary outcomes include changes in quality-of-life scores (TIPS, ADPKD-UIS, EQ-5D-5L, SF-12) and 24-hour urine volume.
- Analysis will utilize linear mixed models with all available creatinine values from week 12 to study completion.
Conclusions
- The HYDRO-PROTECT study is designed to determine if combined HCT and tolvaptan therapy offers superior renoprotection in ADPKD.
- The study will ascertain whether this combination therapy improves tolvaptan's tolerability by reducing aquaresis and enhancing quality of life.
- Findings will inform clinical practice regarding the use of HCT as an adjunct therapy for ADPKD patients treated with tolvaptan.
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