A Randomized, Double-blind, Parallel-controlled, Multi-center Clinical Trial of HuangKui Capsule to Treat Diabetic Kidney Disease
Trial Snapshot
- Phase
- Early Phase 1
- Enrollment
- 414
- Locations
- 1
- Primary Endpoint
- ACR
Study Overview
Brief Summary
- Name of Investigational Products Huangkui capsule.
- Trial Topic A Randomized, Double-blinded, Parallel, controlled, Multicenter Clinical Trial of Huangkui Capsule in Treating Type II Diabetic Nephropathy (DKD)
- Trial Objectives Primary objective:To evaluate HuangKui capsule efficacy for treatment of type II diabetes ACR.
Secondary objective: To evaluate the efficacy of HuangKui capsule on 24-hour urinary protein changes、reduce PCR-increase eGFR, improve micro-inflammatory state, and improving Traditional Chinese medicine clinical efficacy 4. Trial Design Designed as a block randomized, double-blinded, parallel controlled, multi-center clinical trial.
Detailed Description
- Name of Investigational Products Huangkui capsule
- Trial Topic A Randomized, Double-blinded, Parallel, controlled, Multicenter Clinical Trial ofHuangkui Capsule in Treating Type II Diabetic Nephropathy (DKD)
- Trial Objectives Primary objective: To evaluate HuangKui capsule efficacy for treatment of type II diabetes ACR.
Secondary objective: To evaluate the efficacy of HuangKui capsule on 24-hour urinary protein changes、reduce PCR-increase eGFR, improve micro-inflammatory state, and improving Traditional Chinese medicine clinical efficacy. 4. Trial Design Designed as a block randomized, double-blinded, parallel controlled, multi-center clinical tria 4.1 Multi-center: The trial is proposed to be conducted in the department of Nephrology or Endocrinology of nine hospitals simultaneously.
4.2 Randomization:Using stratified block randomized design. The randomization numbers were generated with SAS statistical software.
4.3 Arms: The study subjects were divided into 3 arms: Huangkui arm, controlled arm and combined treatment arm.
4.4 Estimation of subject numbers
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Huangkui
Placebo drug that simulates Irbesartan tablets 150mg /qd, oral dosing; HuangKui Capsule 2.5g/tid, oral dosing
Intervention: Placebo drug that simulates Irbesartan tablets (Drug)
Huangkui
Placebo drug that simulates Irbesartan tablets 150mg /qd, oral dosing; HuangKui Capsule 2.5g/tid, oral dosing
Intervention: HuangKui Capsule (Drug)
controlled
Placebo 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
Intervention: irbesartan tablets (Drug)
controlled
Placebo 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
Intervention: Placebo drug that simulates HuangKui capsule (Drug)
combined treatment
irbesartan tablets 150mg /qd, oral dosing HuangKui Capsule 2.5g/tid, oral dosing.
Intervention: irbesartan tablets (Drug)
combined treatment
irbesartan tablets 150mg /qd, oral dosing HuangKui Capsule 2.5g/tid, oral dosing.
Intervention: HuangKui Capsule (Drug)
Outcomes
Primary Outcomes
ACR
Time Frame: every 4 week，a total of 24 weeks
ACR baseline changes and changes in the rate
Secondary Outcomes
- High sensitivity C(baseline,12-weeks treatment,24-weeks treatment)
- 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)