Back to resultsA Trial of Doxycycline in Renal Disease (ADORE)
Primary Purpose
Chronic Kidney Disease, Cardiorenal Syndrome
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Doxycycline
Placebo (for Doxycycline)
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Disease
Eligibility 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.
Sites / Locations
- Zuckerberg San Francisco General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Doxycycline-Placebo
Placebo-Doxycycline
Arm Description
Doxycycline 20mg capsule for 30 days, 30-day washout, and then placebo capsule for 30 days.
Placebo capsule for 30 days, 30-day washout, and then Doxycycline 20mg capsule for 30 days.
Outcomes
Primary Outcome Measures
Serum markers of fibrosis
Serum collagen type III amino-terminal propeptide (PIIINP), soluble suppression of tumorigenicity 2 (ST2)
Urinary markers of fibrosis
Urinary PIIINP, Urinary alpha-1 macroglobulin (A1M)
Secondary Outcome Measures
Adverse effects
Nausea, rash
Full Information
NCT ID
NCT02753426
First Posted
April 24, 2016
Last Updated
February 5, 2020
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT02753426
Brief Title
A Trial of Doxycycline in Renal Disease
Acronym
ADORE
Official Title
A Trial of Doxycycline in Renal Disease (ADORE)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Cardiorenal Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Doxycycline-Placebo
Arm Type
Other
Arm Description
Doxycycline 20mg capsule for 30 days, 30-day washout, and then placebo capsule for 30 days.
Arm Title
Placebo-Doxycycline
Arm Type
Other
Arm Description
Placebo capsule for 30 days, 30-day washout, and then Doxycycline 20mg capsule for 30 days.
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
Doxycycline 20mg capsule by mouth, twice a day for 30 days.
Intervention Type
Drug
Intervention Name(s)
Placebo (for Doxycycline)
Intervention Description
Inactive pill manufactured to mimic Doxycycline 20mg. Capsule by mouth, twice a for 30 days.
Primary Outcome Measure Information:
Title
Serum markers of fibrosis
Description
Serum collagen type III amino-terminal propeptide (PIIINP), soluble suppression of tumorigenicity 2 (ST2)
Time Frame
3 months
Title
Urinary markers of fibrosis
Description
Urinary PIIINP, Urinary alpha-1 macroglobulin (A1M)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Adverse effects
Description
Nausea, rash
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Dubin, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zuckerberg San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Trial of Doxycycline in Renal Disease
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