scholarly journals Shenzhuo Formula Treatment in Patients With Macroalbuminuria Secondary to Diabetic Kidney Disease: Protocol Update and Statistical Analysis Plan

2021 ◽  
Author(s):  
Yu-Wei ◽  
Ying Zhang ◽  
Yanbo Li ◽  
Ze Yang ◽  
Xinmiao Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Statistical Analysis ◽  
Kidney Disease ◽  
Diabetic Kidney Disease ◽  
Statistical Analysis Plan ◽  
Secondary Outcome ◽  
Selective Reporting ◽  
Clinical Trial Registry ◽  
Diabetic Kidney ◽  
Postprandial Plasma Glucose

Abstract BackgroundDiabetic kidney disease (DKD), as one of the significant complications of diabetes, has been the focus of attention. Our previous retrospective study indicated that Shenzhou Formula (SZF) might reduce the macroalbuminuria secondary to the DKD.Methods and designThis trial is a 24-week, randomized, multicentric, double-blinded, double-dummy clinical trial. 120 DKD patients (60 in each group) will be randomly divided randomized into two groups: SZF+ Irbesartan Simulator or Irbesartan + SZF Simulator. 24-h UP is the primary outcome measure is. The secondary outcome measures include Serum creatinine, estimated glomerular filtration rate, urinary albumin excretion rate, improvement in TCM symptoms, FBG, 2-h postprandial plasma glucose, HbA1C, Cholesterol, triglycerides, HDL, LDL, blood pressure, albumin to creatinine ratio, and the audit of diabetes-dependent quality of life 19 . Our recruitment began in May 2015, and we have enrolled 100 participants in this ongoing study, with a designed maximum sample size of 120. The interim results have been reviewed at N = 60 and continuing recruitment was recommended. This statistical analysis plan includes our approach to impute missing data, analysis primary, secondary outcomes, and safety endpoints.ConclusionThis SAP will standardize the clinical trial's statistical analysis, avoid outcome selective reporting bias and data-driven analysis. This trial will provide further clinical evidence for SZF treatment of macroalbuminuria secondary to DKD.Trial registrationChinese Clinical Trial Registry, ID: ChiCTR-ICR-15006311, registered on 26 May 2013. http://www.chictr.org.cn/showproj.aspx?proj=10862

scholarly journals Oxidized LDL Modifies the Association between Proteinuria and Deterioration of Kidney Function in Proteinuric Diabetic Kidney Disease

Life ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 504
Author(s):  
Stefanos Roumeliotis ◽  
Panagiotis I. Georgianos ◽  
Athanasios Roumeliotis ◽  
Theodoros Eleftheriadis ◽  
Aikaterini Stamou ◽  
...  
Keyword(s):  
Kidney Disease ◽  
Kidney Function ◽  
Diabetic Kidney Disease ◽  
Oxidized Ldl ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Secondary Outcome ◽  
Diabetic Kidney ◽  
Egfr Decline ◽  
Over Time

Proteinuria is characterized by low accuracy for predicting onset and development of diabetic kidney disease (DKD) because it is not directly associated with molecular changes that promote DKD, but is a result of kidney damage. Oxidized low-density lipoprotein (ox-LDL) reflects oxidative stress and endothelial dysfunction, both underlying the development of proteinuria and loss of kidney function in DKD. We aimed to investigate whether ox-LDL modifies the association between proteinuria and progression of DKD in a cohort of 91 patients with proteinuric DKD and diabetic retinopathy, followed for 10 years. The primary endpoint was a combined kidney outcome of eGFR decline ≥30% or progression to end-stage kidney disease. After the end of the study, we considered the percentage change of eGFR over time as our secondary outcome. Proteinuria was associated with both outcomes, and ox-LDL amplified the magnitude of this link (p < 0.0001 for primary and p < 0.0001 for secondary outcome, respectively). After adjustment for duration of diabetes, history of cardiovascular disease and serum albumin, ox-LDL remained a significant effect modifier of the association between proteinuria and eGFR decline over time (p = 0.04). Our study shows that in proteinuric DKD, circulating ox-LDL levels amplified the magnitude of the association between proteinuria and progression of DKD.

scholarly journals JAK1/JAK2 inhibition by baricitinib in diabetic kidney disease: results from a Phase 2 randomized controlled clinical trial

2018 ◽  
Vol 33 (11) ◽  
pp. 1950-1959 ◽  
Author(s):  
Katherine R Tuttle ◽  
Frank C Brosius ◽  
Sharon G Adler ◽  
Matthias Kretzler ◽  
Ravindra L Mehta ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Kidney Disease ◽  
Diabetic Kidney Disease ◽  
Controlled Clinical Trial ◽  
Phase 2 ◽  
Randomized Controlled Clinical Trial ◽  
Diabetic Kidney ◽  
Randomized Controlled ◽  
Jak2 Inhibition

scholarly journals Efficacy, safety and response predictors of adjuvant astragalus for diabetic kidney disease (READY): study protocol of an add-on, assessor-blind, parallel, pragmatic randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e042686
Author(s):  
Kam Wa Chan ◽  
Alfred Siu Kei Kwong ◽  
Pun Nang Tsui ◽  
Simon Chi Yuen Cheung ◽  
Gary Chi Wang Chan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hong Kong ◽  
Kidney Disease ◽  
Adverse Events ◽  
Diabetic Kidney Disease ◽  
End Stage Kidney Disease ◽  
Diabetic Kidney ◽  
Response Predictors ◽  
Randomised Controlled ◽  
End Stage

IntroductionDiabetic kidney disease (DKD) is a prevalent and costly complication of diabetes with limited therapeutic options, being the leading cause of end-stage kidney disease in most developed regions. Recent big data studies showed that add-on Chinese medicine (CM) led to a reduced risk of end-stage kidney disease and mortality among patients with chronic kidney disease (CKD) and diabetes. Astragalus, commonly known as huang-qi, is the most prescribed CM or used dietary herb in China for diabetes and DKD. In vivo and in vitro studies showed that astragalus ameliorated podocyte apoptosis, foot process effacement, mesangial expansion, glomerulosclerosis and interstitial fibrosis. Nevertheless, the clinical effect of astragalus remains uncharacterised. This pragmatic clinical trial aims to evaluate the effectiveness of add-on astragalus in patients with type 2 diabetes, stage 2–3 CKD and macroalbuminuria, and to identify related response predictors.Methods and analysisThis is an add-on, assessor-blind, parallel, pragmatic randomised controlled clinical trial. 118 patients diagnosed with DKD will be recruited and randomised 1:1 to receive 48 weeks of add-on astragalus or standard medical care. Primary endpoints are the changes in estimated glomerular filtration rate and urine albumin-to-creatinine ratio between baseline and treatment endpoint. Secondary endpoints include adverse events, fasting blood glucose, glycated haemoglobin, lipids and other biomarkers. Adverse events are monitored through self-complete questionnaire and clinical visits. Outcomes will be analysed by regression models. Subgroup and sensitivity analyses will be conducted for different epidemiological subgroups and statistical analyses. Enrolment started in July 2018.Ethics and disseminationThis study was approved by the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West/East/Kowloon Central clusters (UW 16-553/HKEC-2019-026/REC (KC/KE)-19-0049/ER-4). We will report the findings in medical journals and conferences. The dataset will be available on reasonable request.Trial registration numberNCT03535935

scholarly journals Xiao Zheng San Jie Granules in the Treatment of Qi Deficiency and Blood Stasis Syndrome in Patients With Diabetic Kidney Disease Stage IV: Protocol for a Randomised, Double-blind, Placebo-controlled, Multi-centre Trial

2021 ◽  
Author(s):  
Sinan Ai ◽  
Yizhen Han ◽  
Yabin Gao ◽  
Yaoxian Wang ◽  
Jingwei Zhou ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Kidney Disease ◽  
Diabetic Kidney Disease ◽  
Blood Stasis ◽  
Stage Iv ◽  
Blood Stasis Syndrome ◽  
Disease Stage ◽  
Double Blind ◽  
Diabetic Kidney ◽  
Double Blind Placebo

Abstract Introduction Diabetic kidney disease (DKD) is a major microvascular complication of diabetes mellitus (DM) and the primary cause of end-stage renal disease. Routine medication might result in adverse effects which limit their usage. Laboratory studies have shown that Xiao Zheng San Jie (XZSJ) granules is effective in reducing the levels of urinary protein and blood creatinine in rats with DKD. Hence, we aim to conduct a clinical trial to determine the efficacy and safety of XZSJ granules among patients with DKD Stage IV, who present with the syndromes of qi deficiency and blood stasis. The purpose of this paper is to report the methodology of this trial.Methods and analysisThis is a randomised, double-blind, placebo-controlled, multi-centre clinical trial. A total of 72 patients with DKD Stage IV who have the syndromes of qi deficiency and blood stasis will be randomly assigned to either intervention or placebo group. In addition to routine medication, the intervention group will be given XZSJ formula (in granules) and the control group will be given placebo for 12-weeks. Data collected at baseline as well as weeks 4, 8 and 12 will be recorded in case report forms and subsequently entered into EpiData 3.1 electronic database. Adverse events will also be documented. Primary outcomes – estimated glomerular filtration rate, urinary albumin-to-creatinine ratio, and serum creatinine – will be assessed after 12 weeks. Ethics and disseminationThis trial has been approved by the Research Ethics Committee of Dongzhimen Hospital (DZMEC-KY-2018-60). Informed consent will be obtained from all participants. Results of this study will be disseminated to the public through academic conferences and peer-reviewed journals.DiscussionThis trial might provide information on an effective method for the treatment of DKD, especially for patients who present with the syndromes of qi deficiency and blood stasis. We hope that this trial will serve as a reference for the conception of high-quality Traditional Chinese Medicine trials in the future, which incorporate syndrome diagnosis into the study design.Trial registration Chinese Clinical Trial Registry, ChiCTR1900021391. Registered 18 February 2018, http://www.chictr.org.cn/showproj.aspx?proj=36106.

scholarly journals Effects of Keluoxin Capsule Combined with Losartan Potassium on Diabetic Kidney Disease: Study Protocol for a Randomized Double-Blind Placebo-Controlled Multicenter Clinical Trial

2020 ◽  
Author(s):  
Rui Wu ◽  
Junping Wei ◽  
Fan Wei ◽  
Lianlian Qu ◽  
Litao Bai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Kidney Disease ◽  
Diabetic Kidney Disease ◽  
Primary Outcome ◽  
Microvascular Complications ◽  
Losartan Potassium ◽  
Multicenter Clinical Trial ◽  
Double Blind ◽  
Diabetic Kidney ◽  
Double Blind Placebo

Abstract Background: Diabetic kidney disease (DKD) is one of the most important microvascular complications of diabetes, and its prevalence has increased dramatically in the past few decades. DKD is responsible for considerable morbidity and mortality of patients with diabetes. Keluoxin capsule (KLX) is a Chinese patent medicine that has been used in the clinic to control DKD for years. Previous studies have shown that KLX appears to reduce proteinuria, but the study protocols as well as the primary outcome need to be improved. Thus, we aim to evaluate whether losartan potassium combined with KLX is more effective than losartan potassium in DKD treatment and to provide validated evidence for the application of KLX in the treatment of DKD.Methods: We will conduct a randomized double-blind placebo-controlled multicenter clinical trial. A total of 252 participants diagnosed with DKD recruited from 18 institutions will be randomly allocated to either a losartan potassium plus KLX (n=126) a losartan potassium plus placebo group (n=126). The participants will be administered KLX or placebo in addition to losartan potassium for 24 weeks. The primary outcome measure will be the decline in estimated glomerular filtration rate (eGFR) (ml/min/1.73 m2/year) from baseline within 24 weeks, and the secondary outcomes will be the incidence of serum creatinine doubling, the incidence of end-stage renal disease (ESRD), the proportion of subjects with a progressive decline in eGFR >30%, the percent change in 24 h urinary total protein (UTP), the change in the urinary albumin/creatinine ratio (UACR), and the total effective rate of the traditional Chinese medicine (TCM) syndrome scale scores. Comparison of the differences in the variables between groups will be performed according to the data revealed by independent t tests, chi-squared tests, Fisher exact tests or Wilcoxon tests. All statistical tests will be two-sided, and significance will be considered for p-values <0.05.Discussion: This study will be the first randomized clinical trial to evaluate the efficacy and safety of KLX versus the placebo for the treatment of patients with DKD. The outcome of this trial will provide a basis for prescribing KLX to patients with DKD.Trial registration: The trial was registered at Chinese Clinical Trial Registry (www.chictr.org.cn) under approval number ChiCTR1900021113 (approval date: 2019/01/29).

scholarly journals Effects of Keluoxin Capsule Combined with Losartan Potassium on Diabetic Kidney Disease: Study Protocol for a Randomized Double-Blind Placebo-Controlled Multicenter Clinical Trial

2020 ◽  
Author(s):  
Rui Wu ◽  
Fan Wei ◽  
Lianlian Qu ◽  
Litao Bai ◽  
Jun Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Kidney Disease ◽  
Diabetic Kidney Disease ◽  
Primary Outcome ◽  
Wilcoxon Test ◽  
Losartan Potassium ◽  
Multicenter Clinical Trial ◽  
Double Blind ◽  
Diabetic Kidney ◽  
Double Blind Placebo

Abstract Background: Diabetic kidney disease (DKD) is one of the most important microvascular complications of diabetes, and its prevalence has increased dramatically in the past few decades. DKD is responsible for considerable morbidity and mortality of patients with diabetes. Keluoxin capsule (KLX) is a Chinese patent medicine that has been used in the clinic to control DKD for years. Previous studies have shown that KLX appears to reduce proteinuria, but the study protocols and the primary outcome need to be improved. Thus, we aim to evaluate whether losartan potassium combined with KLX is more effective than losartan potassium alone in DKD treatment and to provide validated evidence for application of KLX in the treatment of DKD.Methods: We will conduct a randomized double-blind placebo-controlled multicenter clinical trial. A total of 252 participants diagnosed with DKD recruited from 18 institutions will be randomly allocated to either a losartan potassium plus KLX group (n = 126) or a losartan potassium plus placebo group (n = 126). The participants will be administered KLX or placebo in addition to losartan potassium for 24 weeks. The primary outcome measure will be the decline in estimated glomerular filtration rate (eGFR) (ml/min/1.73 m2/year) from baseline within 24 weeks, and the secondary outcomes will be the incidence of serum creatinine doubling, the incidence of end-stage renal disease (ESRD), the proportion of subjects with a progressive decline in eGFR > 30%, the percent change in 24 h urinary total protein (UTP), the change in the urinary albumin/creatinine ratio (UACR), and the total effective rate of the traditional Chinese medicine (TCM) syndrome scale scores. Comparison of the differences in the variables between groups will be carried out according to the data features using an independent t test, chi-square test, Fisher exact test or Wilcoxon test. All statistical tests will be two-sided, and significance will be considered for a p value < 0.05.Discussion: This study will be the first randomized clinical trial to evaluate the efficacy and safety of KLX versus placebo for treatment of patients with DKD. The outcome of this trial will provide a basis for prescribing KLX to patients with DKD.Trial registration: The trial was registered at Chinese Clinical Trial Registry (www.chictr.org.cn) under approval number ChiCTR1900021113 (approval date: 2019/01/29).

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