Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Dec;44(1):461-472.
doi: 10.1080/0886022X.2022.2048017.

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

Yan Cui  1   2 , Ya-Ling Zhai  1   2 , Yuan-Yuan Qi  1   2 , Xin-Ran Liu  1   2 , Ya-Fei Zhao  1   2 , Fu Lv  1   2 , Li-Pei Han  1   2 , Zhan-Zheng Zhao  1   2
Affiliations

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

Yan Cui et al. Ren Fail. 2022 Dec.

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.

Keywords: ClinicalTrials.gov; IgA nephropathy; clinical trials; treatment.

PubMed Disclaimer

Conflict of interest statement

The authors declared no conflicts of interest in this study.

Figures

Figure 1.
Figure 1.
The flowchart of clinical trials extraction.
Figure 2.
Figure 2.
The number of clinical trials registered on ClinicalTrials.gov per year.
Figure 3.
Figure 3.
The general traits of selected clinical trials. (A) During date (observation period); (B) enrollment; (C) participant age; (D) study status. NP: not provided. Notes. Age (years old): child: <18; adult: ≥18 and <65; older adult: ≥65.
Figure 4.
Figure 4.
The characteristics of study design. (A) Study type; (B) study phase; (C) allocation; (D) intervention model; (E) masking; (F) arm. NP: not provided; N/A: not applicable.
Figure 5.
Figure 5.
More elaborate features of selected clinical trials. (A) funder type; (B) data monitoring committee; (C) IPD sharing statement; (D) FDA-regulated product; (E) study results; (F) Region. NP: not provided.
Figure 6.
Figure 6.
Characteristics of trials with results. (A) Study status; (B) mean or median age (years old); (C) Female%; (D) Group; (E) has control group; (F) observation period (months); (G) enrollment who starting trial; (H) enrollment who completing trial. NP: not provided.
See this image and copyright information in PMC

References

    1. Rajasekaran A, Julian BA, Rizk DV.. IgA nephropathy: an interesting autoimmune kidney disease. Am J Med Sci. 2021;361(2):176–194. - PMC - PubMed
    1. Selvaskandan H, Cheung CK, Muto M, et al. . New strategies and perspectives on managing IgA nephropathy. Clin Exp Nephrol. 2019;23(5):577–588. - PMC - PubMed
    1. Bagchi S, Mani K, Swamy A, et al. . Supportive management of IgA nephropathy with Renin-Angiotensin blockade, the AIIMS primary IgA nephropathy cohort (APPROACH) study. Kidney Int Rep. 2021;6(6):1661–1668. - PMC - PubMed
    1. Cheung CK, Barratt J.. Should we STOP immunosuppression for IgA nephropathy? Long-term outcomes from the STOP-IgAN trial. Kidney Int. 2020;98(4):836–838. - PubMed
    1. Rodrigues JC, Haas M, Reich HN.. IgA nephropathy. Clin J Am Soc Nephrol. 2017;12(4):677–686. - PMC - PubMed

MeSH terms

Substances

LinkOut - more resources