Evaluate the Efficacy of Fenofibrate on Microalbuminuria

NCT02314533 | Unknown Phase 4 DMC

• 1 other identifier: FENOD003
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators design this prospective, open-label, parallel, controlled study to investigate fenofibrate's effect on microalbuminuria reduction and serum creatinine on top of statin therapy in Chinese hypertriglyceridemic patients with type 2 diabetes.

Conditions

Microalbuminuria

Outcome Measures

Primary Outcomes (1)

• urinary albumin to creatinine ratio (mg/g)

  6 month

Study Arms (1)

fenofibrate

EXPERIMENTAL

Fenofibrate 200mg capsule will be administered orally with breakfast once daily according to the Chinese prescription information of Lipanthyl, while previous type and dose of statin will be administered in the evening.

Drug: fenofibrate

Interventions

fenofibrate DRUG

Fenofibrate (Lipanthyl®) 200mg capsule will be administered orally with breakfast once daily

Also known as: Lipanthyl

fenofibrate

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females or males, and aged 20 to 65 years.
• Type 2 diabetes with microalbuminuria (Urinary albumin /creatinine ratio, ACR, between 30 and 300 mg/g, a first morning spot urine sample will be used to approximate the 24-hour urine albumin excretion) in two consecutive laboratory tests before the study period.
• At least 2 months statin monotherapy with low to moderate dose (atorvastatin ≤20mg q.d. or rosuvastatin≤10mg q.d. or simvastatin≤40mg q.d. or pravastatin≤40mg q.d.or pitavastatin≤2mg q.d or fluvastatin≤80mg q.d.or lovastatin≤40mg q.d) prior to enrollemnt and plan to continue the same type and dose of statin.
• TG≥1.7 mmol/L (150mg/dl) and TG\<5.65 mmol/L (500mg/dl).
• HbA1C\<8% and blood pressure\<140/90mmHg.

You may not qualify if:

• Any contraindication of fenofibrate and statins in Chinese label.
• Hepatic insufficiency (ALT or AST\> 1.5\*ULN)
• Renal insufficiency \[Creatinine clearance rate (Ccr)\]\<60ml/min estimated from MDRD equation)
• CK \> 1.5\*ULN
• Hypothyroidism
• Use of non-statin lipid-regulating drugs such as niacin and fish oil in previous 1 month
• Combination use of other fibrates or drug with similar structure, especially ketoprofen
• Combination use of oral anticoagulants
• Pregnant or lactating woman
• Other conditions at investigator's discretion

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Related Publications (1)

• Sun X, Liu J, Wang G. Fenofibrate decreased microalbuminuria in the type 2 diabetes patients with hypertriglyceridemia. Lipids Health Dis. 2020 May 23;19(1):103. doi: 10.1186/s12944-020-01254-2.

  PMID: 32446306 DERIVED

MeSH Terms

Interventions

Fenofibrate

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of department of endocrinology

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 11, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 11, 2014

Record last verified: 2014-12