Efficacy, Safety and Response Predictors of Adjuvant Astragalus Therapy for Diabetic Kidney Disease
READY
1 other identifier
interventional
118
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2018
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2018
CompletedFirst Posted
Study publicly available on registry
May 24, 2018
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedDecember 7, 2020
December 1, 2020
4 years
May 13, 2018
December 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in estimated GFR
Efficacy and safety
From baseline to 48 weeks after treatment
Change in spot urine albumin-to-creatinine ratio
Efficacy and safety
From baseline to 48 weeks after treatment
Secondary Outcomes (4)
Change in glycated haemoglobin (HbA1c)
From baseline to 48 weeks after treatment
Change in urinary monocyte chemotactic protein 1 (MCP-1)
From baseline to 48 weeks after treatment
Change in urinary Cystatin C
From baseline to 48 weeks after treatment
Change in lipids
From baseline to 48 weeks after treatment
Other Outcomes (1)
Change in biomarkers related to inflammation and fibrosis
From baseline to 48 weeks after treatment
Study Arms (2)
Standard medical care
ACTIVE COMPARATORAngiotensin converting enzyme inhibitor or angiotensin receptor blocker and oral hypoglycemic agents or insulin
Add on astragalus powder
EXPERIMENTAL3 grams of water soluble astragalus sachets (equivalent to 15g raw herbs) administrated orally on top of standard medical care for 48 weeks.
Interventions
3 grams of water soluble astragalus sachets (equivalent to 15g raw herbs) administrated orally on top of standard medical care for 48 weeks. Patients will have 5 days of medicine per week and will be advised to take the medicine once daily dissolved in boiling water in the first 5 days of the week.
Angiotensin converting enzyme inhibitor or angiotensin receptor blocker
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Queen Mary Hospital
Hong Kong, Hong Kong
School of Chinese Medicine
Hong Kong, Hong Kong
Related Publications (2)
Chan KW, Kwong ASK, Tsui PN, Chan GCW, Choi WF, Yiu WH, Cheung SCY, Wong MMY, Zhang ZJ, Tan KCB, Lao L, Lai KN, Tang SCW; READY and SCHEMATIC research group. Add-on astragalus in type 2 diabetes and chronic kidney disease: A multi-center, assessor-blind, randomized controlled trial. Phytomedicine. 2024 Jul 25;130:155457. doi: 10.1016/j.phymed.2024.155457. Epub 2024 Feb 28.
PMID: 38810556DERIVEDChan KW, Kwong ASK, Tsui PN, Cheung SCY, Chan GCW, Choi WF, Yiu WH, Zhang Y, Wong MM, Zhang ZJ, Tan KCB, Lao L, Tang SCW. 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 Jan 12;11(1):e042686. doi: 10.1136/bmjopen-2020-042686.
PMID: 33436470DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sydney CW TANG, MD, PhD
The University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Assessment of primary outcomes is performed by an independent laboratory
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair of Renal Medicine and Yu Professor in Nephrology
Study Record Dates
First Submitted
May 13, 2018
First Posted
May 24, 2018
Study Start
July 1, 2018
Primary Completion
June 30, 2022
Study Completion
December 31, 2022
Last Updated
December 7, 2020
Record last verified: 2020-12