PMID- 35272573
OWN - NLM
STAT- MEDLINE
DCOM- 20220321
LR  - 20220321
IS  - 1525-6049 (Electronic)
IS  - 0886-022X (Print)
IS  - 0886-022X (Linking)
VI  - 44
IP  - 1
DP  - 2022 Dec
TI  - The comprehensive analysis of clinical trials registration for IgA nephropathy 
      therapy on ClinicalTrials.gov.
PG  - 461-472
LID - 10.1080/0886022X.2022.2048017 [doi]
AB  - 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.
FAU - Cui, Yan
AU  - Cui Y
AD  - Nephrology Hospital, The First Affiliated Hospital of Zhengzhou University, 
      Henan, China.
AD  - Institute of Nephrology, Zhengzhou University, Henan, China.
FAU - Zhai, Ya-Ling
AU  - Zhai YL
AD  - Nephrology Hospital, The First Affiliated Hospital of Zhengzhou University, 
      Henan, China.
AD  - Institute of Nephrology, Zhengzhou University, Henan, China.
FAU - Qi, Yuan-Yuan
AU  - Qi YY
AD  - Nephrology Hospital, The First Affiliated Hospital of Zhengzhou University, 
      Henan, China.
AD  - Institute of Nephrology, Zhengzhou University, Henan, China.
FAU - Liu, Xin-Ran
AU  - Liu XR
AD  - Nephrology Hospital, The First Affiliated Hospital of Zhengzhou University, 
      Henan, China.
AD  - Institute of Nephrology, Zhengzhou University, Henan, China.
FAU - Zhao, Ya-Fei
AU  - Zhao YF
AD  - Nephrology Hospital, The First Affiliated Hospital of Zhengzhou University, 
      Henan, China.
AD  - Institute of Nephrology, Zhengzhou University, Henan, China.
FAU - Lv, Fu
AU  - Lv F
AD  - Nephrology Hospital, The First Affiliated Hospital of Zhengzhou University, 
      Henan, China.
AD  - Institute of Nephrology, Zhengzhou University, Henan, China.
FAU - Han, Li-Pei
AU  - Han LP
AD  - Nephrology Hospital, The First Affiliated Hospital of Zhengzhou University, 
      Henan, China.
AD  - Institute of Nephrology, Zhengzhou University, Henan, China.
FAU - Zhao, Zhan-Zheng
AU  - Zhao ZZ
AD  - Nephrology Hospital, The First Affiliated Hospital of Zhengzhou University, 
      Henan, China.
AD  - Institute of Nephrology, Zhengzhou University, Henan, China.
LA  - eng
PT  - Journal Article
PL  - England
TA  - Ren Fail
JT  - Renal failure
JID - 8701128
RN  - 0 (Immunosuppressive Agents)
SB  - IM
MH  - Adult
MH  - Clinical Trials as Topic/statistics & numerical data
MH  - Comprehension
MH  - Glomerulonephritis, IGA/*drug therapy
MH  - Humans
MH  - Immunosuppressive Agents/*therapeutic use
MH  - Patient Selection
MH  - Randomized Controlled Trials as Topic/*statistics & numerical data
MH  - Treatment Outcome
PMC - PMC8920363
OTO - NOTNLM
OT  - ClinicalTrials.gov
OT  - IgA nephropathy
OT  - clinical trials
OT  - treatment
COIS- The authors declared no conflicts of interest in this study.
EDAT- 2022/03/12 06:00
MHDA- 2022/03/22 06:00
PMCR- 2022/03/10
CRDT- 2022/03/11 05:31
PHST- 2022/03/11 05:31 [entrez]
PHST- 2022/03/12 06:00 [pubmed]
PHST- 2022/03/22 06:00 [medline]
PHST- 2022/03/10 00:00 [pmc-release]
AID - 2048017 [pii]
AID - 10.1080/0886022X.2022.2048017 [doi]
PST - ppublish
SO  - Ren Fail. 2022 Dec;44(1):461-472. doi: 10.1080/0886022X.2022.2048017.