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Statin therapy in patients with early-stage autosomal dominant polycystic kidney disease: Design and baseline
Berenice Y Gitomer1, Wei Wang1, Diana George1
1Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, 13199 East Montview Blvd., Suite 495, Aurora, CO 80045, USA.
Background:
Autosomal dominant polycystic kidney disease (ADPKD) is characterized by the development and continued growth of multiple cysts in the kidneys leading to ultimate loss of kidney function in most patients. Currently, tolvaptan is the only agency approved therapy to slow kidney disease advancement in patients with faster progressing disease underscoring the need for additional ADPKD therapies suitable for all patients. We previously showed that pravastatin slowed kidney disease progression in children and young adults with ADPKD. However, the intervention has not been tested in an adult cohort.
Aims:
The aim of the study is to conduct a single center, randomized, placebo-controlled double-blinded clinical trial to determine the efficacy of pravastatin on slowing kidney disease progression in adult patients with early stage ADPKD.
Methods:
One hundred and fifty adult patients with ADPKD and eGFR ≥60 ml/min/1.73m2 will be enrolled in the study and randomized to receive 40 mg/day pravastatin or placebo for a period of 2-years.
Outcomes:
The primary outcome of the trial is change in total kidney volume assessed by magnetic resonance imaging (MRI). Secondary outcomes include change in kidney function by iothalamate GFR and renal blood flow and markers of inflammation and oxidative stress.
Conclusion:
This study will assess the kidney therapeutic benefits of pravastatin in adult patients with ADPKD. The recruitment goal of 150 subjects was attained and the study is ongoing.
Registration:
This study is registered on Clinicaltrials.gov # NCT03273413.
Insights
Pravastatin may slow kidney disease progression in adults with autosomal dominant polycystic kidney disease (ADPKD). This ongoing clinical trial investigates its efficacy and safety in this patient population.
Area of Science:
- Nephrology
- Pharmacology
- Genetics
Background:
- Autosomal dominant polycystic kidney disease (ADPKD) causes kidney failure in most patients.
- Current treatments like tolvaptan are limited, necessitating new therapies for all ADPKD patients.
- Previous studies indicated pravastatin slows kidney disease progression in younger ADPKD patients.
Purpose of the Study:
- To evaluate the efficacy of pravastatin in slowing kidney disease progression in adult ADPKD patients.
- To assess the impact of pravastatin on total kidney volume and kidney function.
- To explore pravastatin's effects on renal blood flow, inflammation, and oxidative stress markers.
Main Methods:
- A randomized, placebo-controlled, double-blind clinical trial.
- 150 adult ADPKD patients with eGFR ≥60 ml/min/1.73m² enrolled.
- Participants received 40 mg/day pravastatin or placebo for 2 years.
Main Results:
- The study is ongoing, with the recruitment goal of 150 subjects achieved.
- Primary outcome: change in total kidney volume via MRI.
- Secondary outcomes: changes in iothalamate GFR, renal blood flow, inflammation, and oxidative stress.
Conclusions:
- This trial assesses the potential kidney therapeutic benefits of pravastatin in adult ADPKD.
- The study aims to provide evidence for pravastatin as a treatment option for adult ADPKD.
- Results will inform future therapeutic strategies for ADPKD management.
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