Chronic Kidney DiseasePhase 1ADORENCT02753426
A Trial of Doxycycline in Renal Disease
A Phase 1 study testing Doxycycline in people with Chronic Kidney Disease and Cardiorenal Syndrome, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Cardiorenal Syndrome
- What is being tested?
- Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jan 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD pre-dialysis (eGFR< 30 ml/min/1.73m2 not on dialysis);
- local 415/650/510 area codes;
- primary language English or Spanish
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: A Trial of Doxycycline in Renal Disease (ADORE)
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.
Read the 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
- Being tested
- Doxycycline, Placebo (for Doxycycline)
- Medical subject headings
- Renal Insufficiency, Chronic, Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Doxycycline 20mg capsule by mouth, twice a day for 30 days.
Placebo (for Doxycycline)Drug
Inactive pill manufactured to mimic Doxycycline 20mg. Capsule by mouth, twice a for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline-Placebo | Other | Doxycycline 20mg capsule for 30 days, 30-day washout, and then placebo capsule for 30 days. Receives: 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. Receives: Drug: Doxycycline; Drug: Placebo (for Doxycycline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum markers of fibrosis
Serum collagen type III amino-terminal propeptide (PIIINP), soluble suppression of tumorigenicity 2 (ST2)
Measured: 3 months
Urinary markers of fibrosis
Urinary PIIINP, Urinary alpha-1 macroglobulin (A1M)
Measured: 3 months
Secondary outcomes (1)
Adverse effects
Nausea, rash
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruth Dubin, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753426
- Sponsor's protocol ID
- 15-17569
- Acronym
- ADORE
- Status last verified
- Feb 2020
- First submitted
- 24 Apr 2016
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Doxycycline in Renal Disease (ADORE)
- ClinicalTrials.gov ID
- NCT02753426
- Acronym / sponsor ID
- ADORE / 15-17569
- Conditions
- Chronic Kidney Disease, Cardiorenal Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycycline-Placebo | Other | Drug: Doxycycline, Drug: Placebo (for Doxycycline)Doxycycline 20mg capsule for 30 days, 30-day washout, and then placebo capsule for 30 days. |
| Placebo-Doxycycline | Other | Drug: Doxycycline, Drug: Placebo (for Doxycycline)Placebo capsule for 30 days, 30-day washout, and then Doxycycline 20mg capsule for 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CKD pre-dialysis (eGFR< 30 ml/min/1.73m2 not on dialysis);
- local 415/650/510 area codes;
- primary language English or Spanish
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineDoxycycline 20mg capsule by mouth, twice a day for 30 days. | Drug | Doxycycline-Placebo, Placebo-Doxycycline |
| Placebo (for Doxycycline)Inactive pill manufactured to mimic Doxycycline 20mg. Capsule by mouth, twice a for 30 days. | Drug | Doxycycline-Placebo, Placebo-Doxycycline |
Primary outcome
Serum markers of fibrosis
Time frame: 3 months
Serum collagen type III amino-terminal propeptide (PIIINP), soluble suppression of tumorigenicity 2 (ST2)
Urinary markers of fibrosis
Time frame: 3 months
Urinary PIIINP, Urinary alpha-1 macroglobulin (A1M)
1 secondary outcome
Adverse effects
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Dubin, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Doxycycline in people with Chronic Kidney Disease and Cardiorenal Syndrome, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum markers of fibrosis (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.