Efficacy and safety of Abelmoschus manihot for IgA nephropathy: A multicenter randomized clinical trial |
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| Institution: | 1. Department of Nephrology, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Chinese PLA General Hospital, Chinese PLA Medical School, Beijing 100853, China;2. Department of Nephrology, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116011, China;3. Department of Nephrology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200127, China;4. Department of Nephrology, Guang''anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China;5. Department of Nephrology, Da Ping Hospital of Third Military Medical University, Chongqing, 400042, China;6. Department of Nephrology, First Teaching Hospital of Tianjin University of TCM, Tianjin 300192, China;7. Department of Nephrology, The First Hospital of Shanxi Medical University, Taiyuan 030024, China;8. Department of Nephrology, The Six Affiliated Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai 200233, China;9. Department of Nephrology, China-Japan Friendship Hospital, Beijing 100029, China;10. Department of Nephrology, Heilongjiang Provincial Academy of Traditional Chinese Medicine, Heilongjiang, 150036, China;11. Department of Nephrology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, 430061, China;12. Department of Nephrology, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, China;13. Department of Nephrology, Shanxi Provincial People''s Hospital, Xi''an, 710068, China |
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| Abstract: | Rationale and ObjectiveIgA nephropathy (IgAN) is an important cause for end-stage renal disease worldwide. The treatment for IgAN remains challenging, and few randomized and controlled clinical trials have been conducted to evaluate new therapies. The present study assesses the efficacy and safety of Abelmoschus manihot (AM) in IgAN patients.Study DesignRandomized, non-inferiority, double-blind, double-dummy multicenter trial.Setting and ParticipantsThis trial was designed to recruit 1,600 biopsy-proven IgAN patients (proteinuria between 0.5-3.0 g/d and estimated glomerular filtration rate eGFR] of ≥ 45 ml/min/1.73 m2) across China.InterventionsThe participants were randomized at 1:1 to AM (2.5 g for three times per day) or losartan potassium (100 mg per day) for 48 weeks.OutcomesThe primary outcome was the change in 24-hour proteinuria from baseline to week 48. The secondary outcomes were the change in eGFR from baseline to week 48, and the incidents of endpoint events (proteinuria ≥ 3.5 g/24 h, doubling of serum creatinine, or receiving renal replacement treatment).ResultsAmong 1,470 randomized patients (mean age, 37.4 SD, 10.6] years old; 777 52.9%] were female; mean eGFR, 95.0 SD, 24.3] mL/min/1.73 m2; mean 24-hour proteinuria, 1.2 SD, 0.7] g/d), the mean decline in 24-h proteinuria at week 48 was 230 mg and 253 mg in the AM and losartan potassium groups, respectively (P = 0.676). The mean difference in the change in 24-h proteinuria between these two groups was -23.32 mg (95% confident interval: -123.2 to 76.6, p = 0.647). The mean decline in eGFR was 0.41 ml/min/1.73 m2 and 0.76 ml/min/1.73 m2 in the AM and losartan potassium groups, respectively (p = 0.661). The mean difference in the change in eGFR between these two groups was -0.43 ml/min/1.73 m2 (95% confident interval: -1.99 to 1.13, p = 0.589). The incidence of endpoint events was 8.6% in the AM group and 8.2% in the losartan group (p = 0.851).LimitationsThe results of the trial may not be generalized to IgAN patients with a proteinuria of > 3.0 g/d and an eGFR of < 45 ml/min/1.73 m2. The long-term benefits of AM in reducing the risk of progressive renal dysfunction remains unclear, based on this 48-week observation.ConclusionAM can be recommended as a promising treatment for IgAN patients. |
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