Abstract: TH-PO1199
A Phase 3 Randomized Controlled Trial on the Effect of Losartan vs. Add-On Aliskiren in CKD
Session Information
- Late-Breaking Clinical Trials Posters
November 07, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- No subcategory defined
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, y | 55.1(11.1) | 55.0(9.4) |
UP, g/24h | 1.14(1.54) | 0.77(0.81) |
eGFR, ml/min/1.73 m2 BSA | 31.9(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