Evaluation of the contribution of lupus in the distribution of statins to the liver.

Phase 4

• Conditions: Systemic lupus erythematosus

• Registration Number: RBR-6p37zr
• Lead Sponsor: Faculdade de Ciências Farmacêuticas de Ribeirão Preto da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-27
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Healthy Volunteers Group: no active chronic kidney disease; no clinical and laboratory evidence of inflammation; no diagnosis of lupus; age between 18 and 40 years; BMI less than 30 kg / m2; women; normal liver function (birubins, AST, ALT and Gamma-GT); normal renal function (serum urea and creatinine dosage).

Uncontrolled SLE Patients Group: SLEDAI scores between 6 and 12; no active chronic kidney disease; with clinical and laboratory evidence of inflammation; age between 18 and 40 years; BMI less than 30 kg / m2; women; normal liver function (birubins, AST, ALT and Gamma-GT); normal renal function (serum urea and creatinine dosage).

Controlled SLE patients group: SLEDAI scores between 0 and 5; no active chronic kidney disease; with clinical and laboratory evidence of inflammation; age between 18 and 40 years; BMI less than 30 kg / m2; women; normal liver function (birubins, AST, ALT and Gamma-GT); normal renal function (serum urea and creatinine dosage).

Exclusion Criteria

History of severe chronic obstructive pulmonary disease; healthy patients or volunteers treated with MDR1, OATP1B1 and CYP3A inducers or inhibitors.

Study & Design

• Study Type: Intervention
• Study Design: Not specified