Efficacy, Safety and Response Predictors of Adjuvant Astragalus Therapy for Diabetic Kidney Disease

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This add-on open-label randomised controlled pragmatic trial aims to:

1. evaluate the effect of add-on astragalus treatment on type 2 diabetic patients with stage 2 to 3 chronic kidney disease and macroalbuminuria.

2. estimate treatment effect, variance, recruitment rate, attrition rate and change in clinical manifestation including Chinese medicine syndrome for parameters optimisation and feasibility assessment for a subsequent phase III randomised controlled trial.

3. assess response predictors for efficacy and safety among type 2 diabetic patients with stage 2 to 3 chronic kidney disease and macroalbuminuria receiving add-on astragalus treatment

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Collaborator: School of Chinese Medicine, The University of Hong Kong
• Treatments: Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Enzyme Inhibitors

Criteria

Inclusion Criteria:

• diagnosed with type 2 diabetes for at least 5 years;

• with an estimated glomerular filtration rate (GFR) ≥30 ˂90 mL/min/1.73m2 confirmed with repeat testing over three or more months calculated by the abbreviated MDRD study equation;

• persistent macroalbuminuria with spot urine albumin-to-creatinine ratio (UACR) ≥ 300 mg/g confirmed by at least 2 out of 3 consecutive first morning void urine samples;

• on stable dose of anti-diabetic drug including insulin for 12 weeks;

• on stable dose of angiotensin-converting-enzyme inhibitor or angiotensin receptor blocker for 12 weeks; and

• willing and able to give written informed consent

Exclusion Criteria:

• with known history of glomerulonephritis, polycystic kidney disease, systemic lupus erythematosus, any suggestive evidence of nondiabetic glomerulopathy;

• with known history of kidney transplant;

• with concurrent severe disorders of heart, brain, liver, and hematopoietic system, tumor and mental disorder;

• with deranged liver function;

• poorly controlled blood pressure;

• with known history of intolerance or malabsorption of oral medications;

• with uncontrollable urinary infection;

• experiencing pregnancy; or

• participating in other clinical trial within 30 days