The comprehensive analysis of clinical trials registration for IgA nephropathy therapy on ClinicalTrials.gov

Abstract

Objectives IgA Nephropathy (IgAN) is common chronic kidney disease with a high incidence. This study aims to analyze comprehensively therapeutic clinical trials for IgAN registered on ClinicalTrials.gov. Methods Therapeutic trials for IgAN registered on ClinicalTrials.gov. up to 15 August 2021 were obtained. The general characteristics, features of experimental design, treatment strategies, and some main inclusion criteria and outcome measures were accessed. Results A total of 104 therapeutic clinical trials for IgAN were extracted on ClinicalTrials.gov up to 15 August 2021. Most of these trials explored the treatment for primary IgAN confirmed by renal biopsy in adults. Only 9% of all selected trials had results. Forty-five percent of trials recruited 50 or fewer participants, and 73% were adults or older adults. 99% of trials were interventional studies, and of all the interventional trials, 70% of trials were randomized, and 68% exercised a parallel assignment of intervention model. Immunosuppression was the most studied for the treatment of IgAN. Moreover, many novel agents had been increasingly studied in recent years. Furthermore, the inclusion criteria and primary outcome measures in these trials were diverse, and the level of proteinuria and change of proteinuria levels were the most used as inclusion criteria and primary outcome, respectively. Conclusions The majority of therapeutic trials for IgAN were randomized, none masking and parallel-assignment interventional studies, primarily recruiting adult patients as research subjects. These trials had relatively small sample sizes and short observation. Thus, more large-scale, multicenter, and randomized controlled trials are still needed to improve the management for IgAN.

Bridging the 13-Year Evidence Gap: A Time for Age-Inclusive Research

“…However, only 13% of the protocols included children and only 1% were exclusively pediatric. 1 The delay has been seen in the evaluation of the efficacy of renin–angiotensin–aldosterone system inhibition in patients with IgA nephropathy; in adults, there were seven randomized controlled trials involving 610 patients, with the first being published in 1994, 2 in contrast to only two pediatric randomized controlled trials with 93 patients, published from 2007. This equates to a 13-year difference between the adult and pediatric first reported trial data.…”

Corticosteroid Therapy in Immunoglobulin A Nephropathy: A Friend or Foe?

“…In the past few years, with the increasing understanding of the pathogenesis of IgAN (Fig. 1), several clinical trials studying the effects of immunomodulatory agents with various targets such as the complement pathway (in particular C5), a proliferation-inducing ligand, and B-cell activating factor have been initiated with promising early data [8, 54].…”

“…Hit 1: increased circulating galactose-deficient IgA1 (Gd-IgA1) produced by mucosal B lymphocytes. The mucosal defence barrier is disrupted by dysregulated innate immune responses due to genetic predispositions, infection, and other environmental factors [8]. This promotes B-cell activation, differentiation, and proliferation through T-cell-dependent and T-cell-independent mechanisms mediated by a proliferation-inducing ligand (APRIL) and B-cell activation factor (BAFF).…”

Comparative analysis between the safety and efficacy of oral corticosteroids versus corticosteroids pulse therapies in IgA nephropathy

“…Novel targeted therapeutic agents are also increasingly the focus of research, like targeting complement components, cytokines, and chemokines, or endothelin. However, the majority of trials had relatively small sample sizes and short observations [ 7 ].…”