A Trial of Doxycycline in Renal Disease

Chronic Kidney Disease Clinical Trial

— ADORE  

Official title:

A Trial of Doxycycline in Renal Disease (ADORE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02753426
• Other study ID #: 15-17569
• Status: Completed
• Phase: Phase 1
• Start date: April 2016
• Est. completion date: January 2018

Study information

• Verified date: February 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Doxycycline
Doxycycline 20mg capsule by mouth, twice a day for 30 days.
• Placebo (for Doxycycline)
Inactive pill manufactured to mimic Doxycycline 20mg. Capsule by mouth, twice a for 30 days.

Locations

Country	Name	City	State
United States	Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum markers of fibrosis	Serum collagen type III amino-terminal propeptide (PIIINP), soluble suppression of tumorigenicity 2 (ST2)	3 months
Primary	Urinary markers of fibrosis	Urinary PIIINP, Urinary alpha-1 macroglobulin (A1M)	3 months
Secondary	Adverse effects	Nausea, rash	3 months