Safety and Effect of Doxycycline in Patients With Amyloidosis
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ClinicalTrials.gov Identifier: NCT01677286 |
Recruitment Status :
Completed
First Posted : September 3, 2012
Results First Posted : June 6, 2017
Last Update Posted : August 1, 2017
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Sponsor:
Boston University
Information provided by (Responsible Party):
John L. Berk, Boston University
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Amyloidosis |
Intervention |
Drug: Doxycycline 100 mg po bid x 12 months |
Enrollment | 25 |
Participant Flow
Recruitment Details | Patients referred to an amyloidosis center and no longer requiring active treatment to control progressive disease were recruited to the study. |
Pre-assignment Details |
Arm/Group Title | Doxycycline 100 mg po Bid x 12 Months |
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Open-label doxycycline 100 mg twice daily by mouth will be administered to subjects for 12 months. |
Period Title: Overall Study | |
Started | 25 |
Completed | 14 |
Not Completed | 11 |
Baseline Characteristics
Arm/Group Title | Doxycycline 100 mg po Bid x 12 Months | |
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Open-label doxycycline 100 mg twice daily by mouth will be administered to subjects for 12 months. | |
Overall Number of Baseline Participants | 25 | |
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[Not Specified]
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 25 participants | |
65
(36 to 82)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 25 participants | |
Female |
6 24.0%
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Male |
19 76.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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White | Number Analyzed | 25 participants |
24 96.0%
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Multiple | Number Analyzed | 25 participants |
1 4.0%
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Not hispanic or latino | Number Analyzed | 25 participants |
24 96.0%
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Unknown/not reported | Number Analyzed | 25 participants |
1 4.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 25 participants |
25 100.0%
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Brain Natriuretic Peptide (BNP)
[1] [2] Mean (Standard Deviation) Unit of measure: pg/mL |
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Number Analyzed | 12 participants | |
385 (294) | ||
[1]
Measure Description: Study participants with predominant cardiac amyloid involvement.
[2]
Measure Analysis Population Description: Patients with predominant amyloid cardiomyopathy constituted the "cardiac group" (n=12). Serial cardiac biomarkers (BNP, Troponin I) determinations were used to assess the effect of doxycycline on cardiac amyloid disease progression.
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Troponin I
[1] [2] Mean (Standard Deviation) Unit of measure: ng/mL |
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Number Analyzed | 12 participants | |
0.11 (0.07) | ||
[1]
Measure Description: Study participants with predominant cardiac amyloid involvement.
[2]
Measure Analysis Population Description: Patients with predominant amyloid cardiomyopathy constituted the "cardiac group" (n=12). Serial cardiac biomarkers (BNP, Troponin I) determinations were used to assess the effect of doxycycline on cardiac amyloid disease progression.
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Creatinine Clearance (mL/min)
[1] [2] Mean (Standard Deviation) Unit of measure: mL/min |
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Number Analyzed | 10 participants | |
83.3 (36.5) | ||
[1]
Measure Description: Study participants with predominant renal amyloid involvement.
[2]
Measure Analysis Population Description: Patients with predominant amyloid nephropathy constituted the "renal group" (n=10). Serial creatinine clearance and proteinuria were used to assess the effect of doxycycline on renal amyloid disease progression.
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Proteinuria (g/day)
[1] [2] Mean (Standard Deviation) Unit of measure: G/day |
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Number Analyzed | 10 participants | |
5.99 (3.15) | ||
[1]
Measure Description: Study participants with predominant renal amyloid involvement.
[2]
Measure Analysis Population Description: Patients with predominant amyloid nephropathy constituted the "renal group" (n=10). Serial creatinine clearance and proteinuria were used to assess the effect of doxycycline on renal amyloid disease progression.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | John Berk, MD |
Organization: | Boston Medical Center |
Phone: | 617-638-4494 |
EMail: | jberk@bu.edu |
Publications:
Responsible Party: | John L. Berk, Boston University |
ClinicalTrials.gov Identifier: | NCT01677286 |
Other Study ID Numbers: |
H-31546 |
First Submitted: | August 21, 2012 |
First Posted: | September 3, 2012 |
Results First Submitted: | March 19, 2017 |
Results First Posted: | June 6, 2017 |
Last Update Posted: | August 1, 2017 |