Comprehensive Analysis of Clinical Trials Registration for Lupus Nephritis Therapy on ClinicalTrials.gov

Abstract

Objective: Clinical trials are the most effective method for evaluating therapeutic strategies. The purpose of this study was to comprehensively assess the characteristics of trials on lupus nephritis (LN) and provide a reference for LN treatment and research.Methods: Registered therapeutic trials on drug interventions for LN were obtained from ClinicalTrials.gov up to December 3, 2020. The general characteristics, methodological characteristics, detailed characteristics, investigated drugs, eligibility criteria, and outcome measures of these trials were analyzed.Results: A total of 126 eligible trials were evaluated, and these trials mainly investigated the initial treatment of adult proliferative LN. Half of the trials enrolled <50 participants, and 70.7% of the trials lasted for 6–24 months. In total, 95.2% of trials adopted an interventional study design. Of intervention trials, 56.6% were in phase 2 or phase 3, 76.7% were randomized, 77.5% employed a parallel assignment, and 41.7% were masked. The eligibility criteria and outcome measures of the included trials varied and involved a variety of indicators. Chemical agents and biologics are the most widely studied immunotherapies, of which mycophenolate mofetil, tacrolimus, and rituximab are the most studied. In addition, some trials studied cell transplantation treatment.Conclusions: The majority of clinical trials for LN therapy registered on ClinicalTrials.gov investigated the initial treatment of adult proliferative LN, and most of these trials were randomized, parallel assigned, and insufficiently masked interventional trials with small scale, short duration, various eligibility criteria, and outcome measures. We hope that more large-scale, long-term multicenter, and high-quality RCT trials with standardized inclusion criteria/exclusion criteria and treatment effect evaluation systems will be conducted and that more energy and funding will be put into exploring biological products and stem cell therapies. In addition, trials for membranous LN, childhood-onset LN, and maintenance phase LN are needed to establish optimal treatment strategies.

Clinical trials of stem cell-based therapies for pediatric diseases: a comprehensive analysis of trials registered on ClinicalTrials.gov and the ICTRP portal site

“…Joseph S Ross et al reviewed the clinical trials funded by NIH in ClinicalTrials.gov, their results showed that within 30 months of the trials' completion, only 294 (46%) were published in the peer-reviewed journals [23]. Similarly, two studies indicated that around 70% of the studies had no web links for the publications of results on ClinicalTrials.gov [25,26]. Except for the experiment being incomplete, there might exist a number of factors resulting in these low publication rates, including that journals tended to report only "positive" research in terms of publication bias or the researchers did not release their findings [27].…”

Novel Therapeutics for Management of Lupus Nephritis: What Is Next?

“…A comprehensive study of clinical trials in LN registered with ClinicalTrials.gov lists as many as 126 RCTs initiated between 1998 and 2020, including those for 27 types of biological agents. 5 Among these, anti-inflammatory agents act acutely by limiting immunologic damage, making them useful as induction agents. Therapies that target autoimmunity work toward attenuating disease activity and thus prevent accruing damage from repeated flares.…”

Systemic lupus erythematosus: history and modernity

“…Таким образом, проблема фармакотерапии СКВ (табл. 2) продолжает оставаться одной из центральных в современной ревматологии и для ее решения необходима интенсификация клинических и научных исследований [205].…”