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A Trial of Doxycycline in Renal Disease (ADORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02753426
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Cardiorenal Syndrome Drug: Doxycycline Drug: Placebo (for Doxycycline) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Trial of Doxycycline in Renal Disease (ADORE)
Study Start Date : April 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Doxycycline-Placebo
Doxycycline 20mg capsule for 30 days, 30-day washout, and then placebo capsule for 30 days.
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.

Placebo-Doxycycline
Placebo capsule for 30 days, 30-day washout, and then Doxycycline 20mg capsule for 30 days.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Adverse effects [ Time Frame: 3 months ]
    Nausea, rash



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753426


Locations
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United States, California
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Ruth Dubin, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02753426    
Other Study ID Numbers: 15-17569
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Cardio-Renal Syndrome
Urologic Diseases
Renal Insufficiency
Heart Failure
Heart Diseases
Cardiovascular Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents