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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion:

Description

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.

Official Title

A Trial of Doxycycline in Renal Disease (ADORE)

Details

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.

Keywords

Chronic Kidney Disease Cardiorenal Syndrome Kidney Diseases Renal Insufficiency, Chronic Cardio-Renal Syndrome Doxycycline

Eligibility

You can join if…

Open to people ages 18 years and up

  • CKD pre-dialysis (eGFR< 30 ml/min/1.73m2 not on dialysis);
  • local 415/650/510 area codes;
  • primary language English or Spanish

You CAN'T join if...

  • eGFR worsening by greater than 5ml/min/1.73 m2 during the last 6 months;
  • Systolic blood pressure less than 100mmHg or greater than 170 mmHg;
  • pregnancy;
  • ejection fraction less than 45%;
  • NYHA class III or IV HF;
  • myocardial infarction or hospitalization for HF within 4 months;
  • liver disease;
  • moderate or severe chronic obstructive pulmonary disease or pulmonary fibrosis;
  • current infection;
  • chemotherapy;
  • major surgery within last month;
  • bilateral dialysis access precluding lab draw;
  • self-reported use of IV drugs or cocaine within the last 6 months.

Location

  • Zuckerberg San Francisco General Hospital
    San Francisco, California, 94110, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02753426
Phase
Phase 1
Lead Scientist
Ruth Dubin
Study Type
Interventional
Last Updated
October 6, 2017