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Kidney Week

Abstract: TH-PO842

Tolvaptan Slows the Decline of Renal Function in Autosomal Dominant Polycystic Kidney Disease Independent of the Response to Total Kidney Volume: Analysis of the TEMPO 3:4 Japanese Cohort

Session Information

Category: Genetic Diseases of the Kidneys

  • 1001 Genetic Diseases of the Kidneys: Cystic


  • Horie, Shigeo, Juntendo University, Tokyo, Japan
  • Muto, Satoru, Juntendo University, Tokyo, Japan
  • Kawano, Haruna, Juntendo university, Tokyo, Japan
  • Okada, Tadashi, Otsuka Pharmaceutical Co., Ltd., Osaka, Japan
  • Shibasaki, Yoshiyuki, Otsuka Pharmaceutical Co., Ltd., Osaka, Japan
  • Ibuki, Tatsuki, Otsuka Pharmaceutical, Tokushima, Japan

In TEMPO 3:4 (NCT00428948), TLV slowed the increase in TKV and renal function decline over a 3-year period in patients with ADPKD. We conducted a post-hoc analysis of TEMPO 3:4 in the Japanese cohort to determine if there was an association between change in TKV and renal function in patients treated with tolvaptan.


The TLV-treated group of the Japanese cohort of TEMPO 3:4 was subdivided into responders (R; net TKV decrease) and non-responders (NR; net TKV increase) at Year 3. An analysis of potential correlations between TLV treatment and the effects on TKV and eGFR were performed.


147 patients (placebo (PBO): 55; TLV : 92 [R: 37; NR: 55]) were analyzed. At Year 3, the mean changes in TKV for PBO, TLV R, and TLV NR were 16.99%, -8.33% and 13.95%; mean changes in eGFR were -12.61, -8.47 and -8.58 mL/min/1.73 m2. Female gender was a significant predictive factor for TLV inhibition of TKV growth. Compared with PBO, eGFR decline was significantly reduced in both R and NR groups (P<0.05), however, no difference was seen between R and NR. No difference in urine osmolality at Year 1, 2, and 3 was observed between R and NR.


TLV slowed the decline in renal function over a 3-year period in the Japanese cohort of patients irrespective to the effect of TLV on TKV. TLV treatment should not be terminated by the short-time growth of TKV.


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