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| Effects of Niaoduqing Particles (尿毒清颗粒) on Delaying Progression of Renal Dysfunction: A Post-trial, Open-Label, Follow-up Study |
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| KeyWord:chronic kidney disease, moderate-to-severe renal dysfunction, Niaoduqing Particles, post-trial follow-up, Chinese medicine |
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| Abstract: |
| Objective: To follow up the participants of the randomized clinical trial "Efficacy and Safety of Niaoduqing Particles (尿毒清颗粒) for Delaying Moderate-to-Severe Renal Dysfunction", and assess the long-term effects of Niaoduqing Particles on delaying the progression of renal dysfunction. Methods: Participants, who had previously been randomly assigned to receive Niaoduqing Particles or placebo for 24 weeks (146 cases in each group), were invited to follow-up and all were administered Niaoduqing Particles 5 g thrice daily and 10 g before bedtime for 24 weeks. The primary endpoints were changes in baseline serum creatinine (Scr) and estimated glomerular filtration rate (eGFR) after completion of the open-label treatment period. Results: After the double-blind period, the median (interquartile range) changes in Scr were 1.1 (–13.0–24.1) and 11.7 (–2.6–42.9) μmol/L for the Niaoduqing Particle and placebo groups, respectively (P=0.008), and the median changes in eGFRs were –0.2 (–4.3–2.7) and –2.21 (–5.7–0.8) mL?min-1?1.73 m-2, respectively (P=0.016). There were significant differences in the double-blind period changes in renal function between groups. After the open-label period, the median changes in Scr were 9.0 (–10.0–41.9) and 17.5 (–6.0–50.0) μmol/L for the Niaoduqing Particle and placebo groups according to baseline grouping, respectively (P=0.214), and the median changes in eGFRs were –2.3 (–6.4–1.9) and –3.7 (–7.5–1.1) mL?min-1?1.73 m-2, respectively (P=0.134). There were no statistical differences in the open-label period changes in renal function between groups. The eGFR reduction of participants who accepted Niaoduqing Particle treatment for 48 weeks was projected to 2.5 mL?min-1?1.73 m-2 per year. Conclusions: Niaoduqing Particles appear to have long-term efficacy for patients with moderate-to-severe renal dysfunction. Although there was no statistical difference, the early use of Niaoduqing Paticles seems to ameliorate the worsening of renal function. (Trial registration No. ChiCTR-TRC-12002448) |
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