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Completed

NCT Number: NCT02753426

A Trial of Doxycycline in Renal Disease

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Doxycycline

Drug

Doxycycline 20mg capsule by mouth, twice a day for 30 days.

Placebo (for Doxycycline)

Drug

Inactive pill manufactured to mimic Doxycycline 20mg. Capsule by mouth, twice a for 30 days.

Primary outcomes

  1. Serum markers of fibrosis

    Time frame: 3 months

    Serum collagen type III amino-terminal propeptide (PIIINP), soluble suppression of tumorigenicity 2 (ST2)

  2. Urinary markers of fibrosis

    Time frame: 3 months

    Urinary PIIINP, Urinary alpha-1 macroglobulin (A1M)

Secondary outcomes

  1. Adverse effects

    Time frame: 3 months

    Nausea, rash

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

A Trial of Doxycycline in Renal Disease (ADORE)

Acronym: ADORE

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Apr 27, 2016
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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