Clinical Trial of HuangKui Capsule to Treat Diabetic Kidney Disease
A Randomized, Double-blind, Parallel-controlled, Multi-center Clinical Trial of HuangKui Capsule to Treat Diabetic Kidney Disease
1 other identifier
interventional
414
1 country
1
Brief Summary
- 1.Name of Investigational Products Huangkui capsule.
- 2.Trial Topic A Randomized, Double-blinded, Parallel, controlled, Multicenter Clinical Trial of Huangkui Capsule in Treating Type II Diabetic Nephropathy (DKD)
- 3.Trial Objectives Primary objective:To evaluate HuangKui capsule efficacy for treatment of type II diabetes ACR.
- 4.Trial Design Designed as a block randomized, double-blinded, parallel controlled, multi-center clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jan 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 4, 2017
CompletedFirst Posted
Study publicly available on registry
January 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJuly 5, 2017
December 1, 2016
1.3 years
January 4, 2017
July 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
ACR
ACR baseline changes and changes in the rate
every 4 week，a total of 24 weeks
Secondary Outcomes (5)
24-hour urinary protein
every 4 week,，a total of 24 weeks
PCR
every 12 week,，a total of 24 weeks
Glomerular filtration rate
every 12 week,，a total of 24 weeks
TCM syndromes Efficacy endpoint
baseline,12-weeks treatment,24-weeks treatment
High sensitivity C
baseline,12-weeks treatment,24-weeks treatment
Study Arms (3)
Huangkui
EXPERIMENTALPlacebo drug that simulates Irbesartan tablets 150mg /qd, oral dosing; HuangKui Capsule 2.5g/tid, oral dosing
controlled
ACTIVE COMPARATORPlacebo drug that simulates Irbesartan tablets 150mg /qd, oral dosing; HuangKui Capsule 2.5g/tid, oral dosing irbesartan tablets 150mg /qd, oral dosing; Placebo drug that simulates HuangKui capsule 2.5g/tid, oral dosing
combined treatment
OTHERirbesartan tablets 150mg /qd, oral dosing HuangKui Capsule 2.5g/tid, oral dosing.
Interventions
Placebo drug that simulates Irbesartan tablets 150mg /qd, oral dosing
Placebo drug that simulates HuangKui capsule 2.5g/tid, oral dosing
Eligibility Criteria
You may qualify if:
- Aged 18 to 75 years old, male or female
- Meet the diagnostic criteria of type 2 diabetes published by the World Health Organization (WHO) in 1999: fasting plasma glucose\>126mg/dL (or\>7.0mmol/L), 2h postprandial blood glucose\>200mg/dL (or\>11.1mmol/L), or 2h blood glucose in OGTT test\>200mg/dL(11.1mmol/L), random blood glucose test≥200mg/dL(11.1mmol/L)
- Meet Diabetic Kidney Disease (DKD) and the United States Diabetes Association (ADA) and the American Kidney Foundation (NKF) diagnostic criteria in 2007 ; 300mg/g ≤ ACR \<2000mg/g
- e-GFR\>30 mL/min (CKD-Epi formula),
- Glycated hemoglobin ≤8.5%
- Agree to sign informed consent form.
You may not qualify if:
- Type 1 diabetes
- Other secondary glomerulonephritis caused by Non-diabetes disease;
- Taking Huangkui capsule, ACEI and / or ARB drugs within 2 months;
- Taking glucocorticoid, immunosuppressive agents and Tripterygium wilfordii drug history within one month;
- Taking three or more antihypertensive drugs, but the blood pressure is still\>160/90mmHg
- With other diseases, syndromes, or comorbidities that may affect the diagnosis and therapeutic effect of the target indications
- The treatments received may affect the evaluation of efficacy and safety endpoints
- With phychological or pathological conditions which may affect the evaluation of efficacy endpoints and safety endpointssuch as the menstrual period, or heart, brain, liver and hematopoietic system and other serious primary disease
- With high risk, such as pregnant women or childbearing during the trial, be allergy to the Abelmoschus Moschatus Capsule and irbesartan, in the dangerous condition with unexpected accidents.
- Alcohol or drug abuse
- Noncompliance, such as unwilling to accept research procedures or suffering from mental illness and other diseases
- Other: Such as poor compliance, or can not attend the follow-up visit in time for some reasons;
- Is participating in another clinical study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jiangsu Province Hospital of TCM
Nanjing, Jiangsu, China
Related Publications (1)
Zhao J, Tostivint I, Xu L, Huang J, Gambotti L, Boffa JJ, Yang M, Wang L, Sun Z, Chen X, Liou-Schischmanoff A, Baumelou A, Ma T, Lu G, Li L, Chen D, Pieroni L, Liu B, Qin X, He W, Wang Y, Gu HF, Sun W. Efficacy of Combined Abelmoschus manihot and Irbesartan for Reduction of Albuminuria in Patients With Type 2 Diabetes and Diabetic Kidney Disease: A Multicenter Randomized Double-Blind Parallel Controlled Clinical Trial. Diabetes Care. 2022 Jul 7;45(7):e113-e115. doi: 10.2337/dc22-0607. No abstract available.
PMID: 35613364DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2017
First Posted
January 11, 2017
Study Start
January 1, 2017
Primary Completion
May 1, 2018
Study Completion
December 1, 2018
Last Updated
July 5, 2017
Record last verified: 2016-12