Berberine Prevent Contrast-induced Nephropathy in Patients With Diabetes

NCT02808351 | Completed Phase 4 DMC

• 1 other identifier: NFH20160611
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Major adverse renal events

  30 days

Study Arms (2)

Berberine

EXPERIMENTAL

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.

Drug: Berberine

Blank control

NO INTERVENTION

Blank control of berberine administration

Interventions

Berberine DRUG

Berberine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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％)

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

MeSH Terms

Conditions

Diabetes Mellitus; Renal Insufficiency, Chronic

Interventions

Berberine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Shaoliang Chen

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology and Cath Lab, Vice President of Nanjing First Hospital

Study Record Dates

• First Submitted: June 12, 2016
• First Posted: June 21, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)