Clinical Trial: Doxycycline: A Novel Treatment for Cardiorenal Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Doxycycline: A Novel Treatment for Cardiorenal Syndrome

Brief 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 Summary: 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.
Sponsor: University of California, San Francisco

Current Primary Outcome:

  • Serum markers of fibrosis [ Time Frame: 3 months ]
    Serum collagen type III amino-terminal propeptide (PIIINP), soluble suppression of tumorigenicity 2 (ST2)
  • Urinary markers of fibrosis [ Time Frame: 3 months ]
    Urinary PIIINP, Urinary alpha-1 macroglobulin (A1M)


Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse effects [ Time Frame: 3 months ]

Nausea, rash


Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: April 24, 2016
Date Started: April 2016
Date Completion: August 2017
Last Updated: May 9, 2017
Last Verified: May 2017