Berberine Prevent Contrast-induced Nephropathy in Patients With Diabetes
Primary Purpose
Diabetes Mellitus, Chronic Kidney Disease
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Berberine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Planned diagnostic coronary or peripheral artery angiography
- Type 2 diabetes mellitus
- CKD stages ≥2
- Statin naive, or not on statin treatment for at least 14 days
- Withdrawal metformin or aminophylline for 48h before angiography
- Total iodixanol volume
Exclusion Criteria:
- Hypersensitivity to iodine-containing compounds and berberine
- Ketoacidosis
- Lactic acidosis
- CKD stages 1, 5 (eGFR≥90ml/min per 1.73m2 or eGFR<15ml/min per 1.73m2)
- STEMI
- NYHA class IV or hemodynamic instability
- Administration of any iodinated contrast medium within 14 days before randomization
- LDL-C<1.82mmol/L(70mg/dL)
- Hepatic dysfunction (ALT 3 times greater than upper normal limit)
- Thyreoid insufficiency
- Renal artery Stenosis(unilateral >70% or bilateral stenosis>50%)
Sites / Locations
- Nanjing First Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Berberine
Blank control
Arm Description
Preoperative berberine 300 mg administration for at least 6 hours before interventional procedure, post-procedure berberine administration 100 mg at 24, 48 hours after procedure.
Blank control of berberine administration
Outcomes
Primary Outcome Measures
Contrast-induced nephropathy
An absolute increase in serum creatinine (SCr) >=0.5mg/dL(>=44.2μmmol/L)or a >= 25% increase in SCr from baseline to 72 hours after the procedure
Secondary Outcome Measures
Major adverse renal events
The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes.
Full Information
NCT ID
NCT02808351
First Posted
June 12, 2016
Last Updated
March 26, 2022
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02808351
Brief Title
Berberine Prevent Contrast-induced Nephropathy in Patients With Diabetes
Official Title
Multicenter Randomized Controlled Study of Berberine for Prevention of Contrast-Induced Acute Kidney Injury in Patients With Diabetes and Renal Insufficient
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced nephropathy (CIN). Major risk factors for CIN include older age, diabetes mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs, hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning that in a patient with CKD it amplifies the risk of CIAKI.
The aim of this multicenter prospective, randomized, controlled study is to evaluate whether berberine treatment during and after the perioperative period would reduce the risk of CIN in a high-risk population of patients with both DM and CKD undergoing coronary angiography or noncoronary angiography, and the influence of such potential benefit on short-term outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Chronic Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
800 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Berberine
Arm Type
Experimental
Arm Description
Preoperative berberine 300 mg administration for at least 6 hours before interventional procedure, post-procedure berberine administration 100 mg at 24, 48 hours after procedure.
Arm Title
Blank control
Arm Type
No Intervention
Arm Description
Blank control of berberine administration
Intervention Type
Drug
Intervention Name(s)
Berberine
Primary Outcome Measure Information:
Title
Contrast-induced nephropathy
Description
An absolute increase in serum creatinine (SCr) >=0.5mg/dL(>=44.2μmmol/L)or a >= 25% increase in SCr from baseline to 72 hours after the procedure
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Major adverse renal events
Description
The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Planned diagnostic coronary or peripheral artery angiography
Type 2 diabetes mellitus
CKD stages ≥2
Statin naive, or not on statin treatment for at least 14 days
Withdrawal metformin or aminophylline for 48h before angiography
Total iodixanol volume
Exclusion Criteria:
Hypersensitivity to iodine-containing compounds and berberine
Ketoacidosis
Lactic acidosis
CKD stages 1, 5 (eGFR≥90ml/min per 1.73m2 or eGFR<15ml/min per 1.73m2)
STEMI
NYHA class IV or hemodynamic instability
Administration of any iodinated contrast medium within 14 days before randomization
LDL-C<1.82mmol/L(70mg/dL)
Hepatic dysfunction (ALT 3 times greater than upper normal limit)
Thyreoid insufficiency
Renal artery Stenosis(unilateral >70% or bilateral stenosis>50%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaoliang Chen
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Berberine Prevent Contrast-induced Nephropathy in Patients With Diabetes
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