NCT02753426

A Trial of Doxycycline in Renal Disease

A Trial of Doxycycline in Renal Disease (ADORE)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this trial is to evaluate whether subantimicrobial-dose of doxycycline (20mgBID) will affect serum and urine biomarkers of fibrosis in patients with pre-dialysis chronic kidney disease.

Detailed description

This is a Phase I, placebo-controlled, randomized crossover trial to determine the effects of 4-week treatment with subantimicrobial-dose doxycycline on serum and urine biomarkers of fibrosis in patients with pre-dialysis chronic kidney disease (eGFR\<30ml/min/1.73m2). Doxycycline is a matrix metalloproteinase inhibitor and is approved for use as an anti-fibrotic in the setting of gum and skin disease at low doses (20mgBID). At such a dose, serum levels are too low for antimicrobial effect and chronic usage is not thought to lead to tetracycline resistance. Investigators hypothesize that doxycycline will ameliorate cardiac and renal fibrosis and thus investigators will detect a decrease in fibrotic markers during treatment with doxycycline.

Conditions

• Chronic Kidney Disease
• Cardiorenal Syndrome

Interventions

Type	Name	Description
DRUG	Doxycycline	Doxycycline 20mg capsule by mouth, twice a day for 30 days.
DRUG	Placebo (for Doxycycline)	Inactive pill manufactured to mimic Doxycycline 20mg. Capsule by mouth, twice a for 30 days.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-12-01
• Completion: 2018-01-01
• First posted: 2016-04-27
• Last updated: 2020-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study