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Safety and Effect of Doxycycline in Patients With Amyloidosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01677286
First Posted: September 3, 2012
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
John L. Berk, Boston University
Results First Submitted: March 19, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Amyloidosis
Intervention: Drug: Doxycycline 100 mg po bid x 12 months

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients referred to an amyloidosis center and no longer requiring active treatment to control progressive disease were recruited to the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Doxycycline 100 mg po Bid x 12 Months Open-label doxycycline 100 mg twice daily by mouth will be administered to subjects for 12 months.

Participant Flow:   Overall Study
    Doxycycline 100 mg po Bid x 12 Months
STARTED   25 
COMPLETED   14 
NOT COMPLETED   11 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Doxycycline 100 mg po Bid x 12 Months Open-label doxycycline 100 mg twice daily by mouth will be administered to subjects for 12 months.

Baseline Measures
   Doxycycline 100 mg po Bid x 12 Months 
Overall Participants Analyzed 
[Units: Participants]
 		 25 
Age 
[Units: Years]
Median (Full Range) 		 
Participants Analyzed 
[Units: Participants]
 		 25 
   65 
 (36 to 82) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Participants Analyzed 
[Units: Participants]
 		 25 
Female      6  24.0% 
Male      19  76.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants 		 
White   
Participants Analyzed 
[Units: Participants]
 		 25 
White   24 
Multiple   
Participants Analyzed 
[Units: Participants]
 		 25 
Multiple   1 
Not hispanic or latino   
Participants Analyzed 
[Units: Participants]
 		 25 
Not hispanic or latino   24 
Unknown/not reported   
Participants Analyzed 
[Units: Participants]
 		 25 
Unknown/not reported   1 
Region of Enrollment 
[Units: Participants]
Count of Participants 		 
United States   
Participants Analyzed 
[Units: Participants]
 		 25 
United States   25 
Brain Natriuretic Peptide (BNP) [1] [2] 
[Units: pg/mL]
Mean (Standard Deviation) 		 
Participants Analyzed 
[Units: Participants]
 		 12 
   385  (294) 
[1] Study participants with predominant cardiac amyloid involvement.
[2] 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.
Troponin I [1] [2] 
[Units: ng/mL]
Mean (Standard Deviation) 		 
Participants Analyzed 
[Units: Participants]
 		 12 
   0.11  (0.07) 
[1] Study participants with predominant cardiac amyloid involvement.
[2] 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.
Creatinine Clearance (mL/min) [1] [2] 
[Units: mL/min]
Mean (Standard Deviation) 		 
Participants Analyzed 
[Units: Participants]
 		 10 
   83.3  (36.5) 
[1] Study participants with predominant renal amyloid involvement.
[2] 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.
Proteinuria (g/day) [1] [2] 
[Units: G/day]
Mean (Standard Deviation) 		 
Participants Analyzed 
[Units: Participants]
 		 10 
   5.99  (3.15) 
[1] Study participants with predominant renal amyloid involvement.
[2] 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.


  Outcome Measures
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1.  Primary:   Amyloid Cardiomyopathy: BNP   [ Time Frame: 12 months ]
  Show Outcome Measure 1

2.  Primary:   Amyloid Cardiomyopathy: Troponin I   [ Time Frame: 12 months ]
  Show Outcome Measure 2

3.  Primary:   Amyloid Nephropathy: Creatinine Clearance   [ Time Frame: 12 months ]
  Show Outcome Measure 3

4.  Primary:   Amyloid Nephropathy: Proteinuria   [ Time Frame: Data were assessed at baseline, 6 and 12 months, with change at end of study reported ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: John Berk, MD
Organization: Boston Medical Center
phone: 617-638-4494
e-mail: jberk@bu.edu


Publications:


Responsible Party: John L. Berk, Boston University
ClinicalTrials.gov Identifier: NCT01677286     History of Changes
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



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