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Kidney Week

Abstract: TH-PO1199

A Phase 3 Randomized Controlled Trial on the Effect of Losartan vs. Add-On Aliskiren in CKD

Session Information

Category: CKD (Non-Dialysis)

Authors

  • Tang, Sydney C.W., The University of Hong Kong, Hong Kong, Hong kong, China
  • Chan, Kam wa, The University of Hong Kong, Hong Kong, Hong kong, China
  • Yap, Desmond Y.H., Queen Mary Hospital, Hong Kong, HONG KONG, China
  • Chan, Gary Chi Wang, Queen Mary Hospital, Hong Kong, HONG KONG, China
  • Lai, Kar Neng, The University of Hong Kong, Hong Kong, Hong kong, China
Background

The potential long-term safety and efficacy of aliskiren in non-diabetic CKD is unknown.

Methods

Non-diabetic CKD stages 3-4 patients were randomized to receive aliskiren added on to losartan (maximal tolerated dose) or losartan alone. The primary outcome was the slope of eGFR at 3 years, along with other secondary endpoints. Composite renal outcomes of doubling of baseline serum creatinine (sCr) or a 40% reduction in eGFR or incident end-stage renal disease (ESRD) or death was analysed as post-hoc analysis.

Results

After follow-up of 144 weeks in 76 subjects (Table 1), there was no difference in the slope of eGFR (Fig 1). 6 patients receiving aliskiren and 7 control patients reached the renal composite endpoint (16.2% vs. 17.9%, P=0.84). Cardiovascular events rate was 10.8% vs. 2.6%, P=0.217. Hyperkalemia rate was 18.9% vs. 5.1% (Fig 2).

Conclusion

Compared to losartan alone, add-on aliskiren conferred no further renoprotective benefit but increased hyperkalemia risks in non-diabetic CKD patients.

Baseline demographics
 Aliskiren Group (N=37)Control Group (N=39)
Age, y55.1(11.1)55.0(9.4)
UP, g/24h1.14(1.54)0.77(0.81)
eGFR, ml/min/1.73 m2 BSA31.9(9.0)27.7(9.0)

Fig 1. Slope of eGFR. Adjusted mean of eGFR (95 CI) by mixed model adjusted for baseline, treatment, trial visit, interaction between trial visit and baseline. P (χ2 test)=0.52 for intergroup difference.

Fig 2. Cumulative incidence of hyperkalemia with 95% CI. Adjusted HR=7.71