Berberine Prevent Contrast-induced Nephropathy in Patients With Diabetes

Phase 4

Completed

• Conditions: Diabetes Mellitus; Chronic Kidney Disease
• Interventions: Drug: Berberine

• Registration Number: NCT02808351
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-12
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-21
• Study Start: 2016-07
• Primary Completion: 2021-12
• Study Completion: 2021-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-26
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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

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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％)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Berberine	Berberine	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.

Primary Outcome Measures

Name	Time	Method
Contrast-induced nephropathy	72 hours	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

Name	Time	Method
Major adverse renal events	30 days	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.

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China