CHARACTERISTICS OF THE SCREENED STUDY POPULATION IN THE PREVENT-ADPKD TRIAL

ATY WONG1, C MANNIX1, J ZHANG1, DCH HARRIS1,2, VW LEE1,2, K SUD2,3, C WOOLNOUGH4 GK RANGAN1,2,3 ON BEHALF OF THE PREVENT-ADPKD TRIAL GROUP.

1Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney, Sydney, NSW; 2Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District, Sydney, NSW; 3Nepean Clinical School, Department of Renal Medicine, Nepean Hospital, University of Sydney, Sydney, NSW; 4Chemical Pathology, Royal Prince Alfred Hospital, Camperdown, NSW

Aim: To describe the characteristics of adults with autosomal dominant kidney disease (ADPKD) screened in the PREVENT-ADPKD trial.

Background: PREVENT-ADPKD is an investigator-initiated, multi-centre, parallel group randomised controlled trial designed to determine the efficacy of water intake prescribed to reduce urine osmolality to <270 mosmol/kg and systemic levels of vasopressin to prevent the progression of height-adjusted total kidney volume (ht-TKV) in ADPKD.

Methods: Adults (18-65yrs) diagnosed with ADPKD with CKD-EPI eGFR ≥30 mL/min/1.73m2 and able to complete magnetic resonance imaging (MRI) were included. Data from the first 50% of intended recruitment target (n=90) were analysed.

Results: The mean±SD age, gender, BMI, serum creatinine and eGFR of the cohort was 43±11 yrs, M:F 53:47%, 26±7 kg/m2, 95±32 µmol/L and 75±17 ml/min/1.73m2 respectively. The mean ht-TKV was 806±530 ml/m with the distribution of estimated annual TKV growth rate categories of <1.5%/yr (1A), 1.5-3.0%/yr (1B), 3-4.5%/yr (1C), 4.5-6%/yr (1D) and >6%/yr (1E) being 11.7, 23.3, 29.9, 27.2 and 7.8% respectively. The mean blood pressure (BP) was 133+82 mm Hg, and 13.6% had normal BP, 49% high-normal BP, 31% Grade 1 hypertension and 7% Grade 2 hypertension. Ht-TKV had a moderate correlation with log-transformed baseline serum copeptin (r=0.46, P<0.05) and serum creatinine (r=0.69, P<0.01) but by multi-variate analysis only the latter was a significant predictor. There were no baseline differences between gender except, height, serum creatinine and body weight which were all higher in men (P<0.05)

Conclusions: The screened population has similar characteristics to other clinical trial cohorts. Prognostic enrichment (exclusion of Mayo Subclass IA which constitute ~10% of screened population) will be used to select patients with a high-risk of progression.

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