Abstract
BackgroundIgA nephropathy (IgAN) is one of the most common primary glomerular diseases worldwide, but effective therapy remains limited and many patients progress to end-stage renal disease (ESRD). Only angiotensin-converting enzyme inhibitors (ACE-I)/angiotensin-receptor blockers (ARB) show a high level of evidence (1B level) of being of value in the treatment for IgAN according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. However, traditional Chinese medicine has raised attention in kidney disease research. Abelmoschus manihot, a single medicament of traditional Chinese medicine has shown therapeutic effects in primary glomerular disease according to the randomized controlled clinical trial that we have completed. Here, we conduct a new study to assess the efficacy and safety of Abelmoschus manihot in IgAN. Also, this study is currently the largest double-blind, randomized controlled registered clinical research for the treatment of IgAN.MethodsWe will conduct a multicenter, prospective, double-blind, double-dummy randomized controlled study. The study is designed as a noninferiority clinical trial. Approximately 1600 biopsy-proven IgAN patients will be enrolled at 100 centers in China and followed up for as long as 48 weeks. IgAN patients will be randomized assigned to the Abelmoschus manihot group (in the form of a huangkui capsule, 2.5 g, three times per day) and the losartan potassium group (losartan potassium, 100 mg/d). The primary outcome is the change in 24-h proteinuria from baseline after 48 weeks of treatment. Change in estimated glomerular filtration rate (eGFR) from baseline after 48 weeks of treatment, the incidence of endpoint events (proteinuria ≥3.5 g/24 h, the doubling of serum creatinine, or receiving blood purification treatment) are the secondary outcomes. Twenty-four-hour proteinuria and eGFR are measured at 0, 4, 12, 24, 36 and 48 weeks.DiscussionThis study will be of sufficient size and scope to evaluate the efficacy and safety of Abelmoschus manihot compared to losartan potassium in treating patients with IgAN. The results of this study may provide a new, effective and safe treatment strategy for IgAN.Trial registrationClinicalTrials.gov, identifier: NCT02231125. Registered on 30 August 2014.
Highlights
IgA nephropathy (IgAN) is one of the most common primary glomerular diseases worldwide, but effective therapy remains limited and many patients progress to end-stage renal disease (ESRD)
IgA nephropathy (IgAN) is the most common primary glomerular disease worldwide, and it is an important cause of chronic kidney disease (CKD) and end-stage renal disease (ESRD) [1, 2]
Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Glomerulonephritis recommends angiotensin-converting enzyme inhibitors (ACE-I)/angiotensin-receptor blocker (ARB), corticosteroids, and immunosuppressive agent treatment according to the level of the urinary protein and renal function of IgAN patients [4]
Summary
Objectives The objective of the trial is to assess the clinical effects and safety of AM in IgAN patients. Study outcomes Primary and secondary outcome measure The primary outcome is the change in 24-h proteinuria from baseline after 48 weeks of treatment For this measurement, patients are instructed to collect urine over 24 h (from 07:00 to 07:00 the day). Original medical records and informed consents are archived in the participating centers and saved for at least 5 years after the clinical trials finish. In the process of the clinical trial, any SAEs must be immediately reported to the principal investigator, the Medical Ethics Committee of the Chinese People’s Liberation Army General Hospital, and to Safety Supervision of CFDA within 24 h. After all patients complete follow-up data records, the database will be locked by Peking University Clinical Research Institute. The Executive Committee will write the report and our final report will follow Consolidated Standards of Reporting Trials (CONSORT) guidelines [15]
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