A Trial of Doxycycline in Renal Disease

NCT ID: NCT02753426

Last Updated: 2020-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-01-31

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.

Conditions

Chronic Kidney Disease; Cardiorenal Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Doxycycline-Placebo

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

Group Type: OTHER

Doxycycline

Intervention Type: DRUG

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

Placebo (for Doxycycline)

Intervention Type: DRUG

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.

Group Type: OTHER

Doxycycline

Intervention Type: DRUG

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

Placebo (for Doxycycline)

Intervention Type: DRUG

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

Interventions

Doxycycline

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

Intervention Type: DRUG

Placebo (for Doxycycline)

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruth Dubin, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Countries

United States

Other Identifiers

15-17569

Identifier Type: -

Identifier Source: org_study_id