Berberine Prevent Contrast-induced Nephropathy in Patients With Diabetes

Diabetes Mellitus Clinical Trial

Official title:

Multicenter Randomized Controlled Study of Berberine for Prevention of Contrast-Induced Acute Kidney Injury in Patients With Diabetes and Renal Insufficient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808351
• Other study ID #: NFH20160611
• Status: Completed
• Phase: Phase 4
• Start date: July 2016
• Est. completion date: December 2021

Study information

• Verified date: March 2022
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%)

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Berberine

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	72 hours
Secondary	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.	30 days