A Trial of Doxycycline in Renal Disease

NCT02753426 | Completed Phase 1 FDA Drug

• 1 other identifier: 15-17569
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Cardiorenal Syndrome

Outcome Measures

Primary Outcomes (2)

• Serum markers of fibrosis

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

  3 months

• Urinary markers of fibrosis

  Urinary PIIINP, Urinary alpha-1 macroglobulin (A1M)

  3 months

Secondary Outcomes (1)

• Adverse effects

  3 months

Study Arms (2)

Doxycycline-Placebo

OTHER

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

Drug: Doxycycline; Drug: Placebo (for Doxycycline)

Placebo-Doxycycline

OTHER

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

Drug: Doxycycline; Drug: Placebo (for Doxycycline)

Interventions

Doxycycline DRUG

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

Doxycycline-Placebo; Placebo-Doxycycline

Placebo (for Doxycycline) DRUG

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

Doxycycline-Placebo; Placebo-Doxycycline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardio-Renal Syndrome

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Failure; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Ruth Dubin, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2016
• First Posted: April 27, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: February 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)