Renal protection from intensive blood pressure treatment with Brand X
Trial design
- Phase 3, multi-center, double-blind RCT conducted globally at over 100 sites
- Enrolled 1,284 patients with hypertension + non-end stage CKD, randomized 1:1 to Brand X or placebo plus standard of care
- 48 week study period assessing change in eGFR from baseline
Key Inclusion Criteria:
- Ages 30-85 years
- Documented hypertension + CKD (eGFR 25-60 mL/min/1.73m2)
- Urinary albumin/creatinine ratio ≥ 30 mg/g
Results
The primary endpoint was mean change in eGFR from baseline over 48 weeks. Key results:
- Brand X group had significantly attenuated eGFR reduction of -3.2 mL/min/1.73m2 compared to placebo group reduction of -5.1 (p<0.001)
- Albuminuria decreased by 31% with Brand X vs 4% increase with placebo (p<0.05)
- BP reductions were superior with Brand X supporting renal protection
Conclusion
The REINFORCE trial demonstrated Brand X treatment effectively preserved kidney function and improved markers of renal damage like albuminuria versus standard of care alone in patients with hypertension complicated by moderate CKD.