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Abstract: TH-PO428

Baseline Characteristics of Participants in Statin Therapy in Patients with Early-Stage ADPKD Clinical Trial

Session Information

Category: Genetic Diseases of the Kidneys

  • 1201 Genetic Diseases of the Kidneys: Cystic

Authors

  • Gitomer, Berenice Y., University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
  • Wang, Wei, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
  • George, Diana, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
  • Nowak, Kristen L., University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
  • Britz, Mallory, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
  • Klawitter, Jelena, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
  • Jovanovich, Anna, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
  • You, Zhiying, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
  • Farmer, Beverly, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
  • Chonchol, Michel, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
Background

At present tolvaptan is the only agency approved therapy to slow kidney disease in patients with faster progressing autosomal dominant polycystic kidney disease (ADPKD). However, aquaretic side effects limit use for some patients, underscoring the need for identification of additional ADPKD therapies. We previously showed that pravastatin treatment slowed kidney cystic disease progression in children and young adults with ADPKD. In order to assess whether pravastatin slows disease progression in an adult population with ADPKD we designed a randomized double blind placebo-controlled trial (NCT03273413).

Methods

150 subjects with an ADPKD diagnosis and early stage kidney disease (eGFR ≥ 60 ml/min/1.73m2) were included in the study. Subjects were recruited nationally and study visits were conducted at the University of Colorado Renal Research Clinic. Baseline visits were ongoing between 2017 and 2022. All participants were randomized to receive either study drug, 40 mg of pravastatin or matching placebo each day for a 2-year period. Baseline assessments included demographics, medical history, total kidney volume (TKV) and renal blood flow (RBF) by magnetic resonance imaging, Glofil-125 (Iothalamate-125) nuclear medicine assessment of measured GFR (mGFR) and routine blood chemistries including creatinine for eGFR by CKD-Epi equation.

Results

Participant mean age and standard deviation was 40 ± 10 years and 65% of subjects were female. There was good agreement between baseline eGFR (90 ± 20 ml/min/1.73m2) and mGFR (92 ± 20 ml/min/1.73m2) r = 0.7, P< 0.0001. Renal blood flow (682 ± 193 ml/min/1.73m2) was positively correlated with both eGFR (P<0.0001) and mGFR (P<0.0001) and negatively correlated with natural log height corrected TKV (P< 0.004) Median height corrected TKV ml/m (IQR) 687 (468,1026).

Conclusion

The target goal for subject recruitment was attained. Subject recruitment spanned a longer than expected period due to travel and University restrictions related to the COVID-19 epidemic. The clinical trial is currently ongoing with the last participant scheduled to complete the end-of-study 2-year visit in March 2024.

Funding

  • Other U.S. Government Support