Trial · NCT01677286
Safety and Effect of Doxycycline in Patients With Amyloidosis
NCT01677286, Phase 2, Completed, Boston University; results first posted 2017-06-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Effect of Doxycycline in Patients With Amyloidosis. Trials, record NCT01677286. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01677286
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Effect of Doxycycline in Patients With Amyloidosis
- NCT number
- NCT01677286
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Boston University
- Conditions
- Amyloidosis
- Interventions
- Doxycycline 100 mg po bid x 12 months
- First posted
- 2012-09-03
- Last updated
- 2017-08-01
- Results first posted
- 2017-06-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Amyloid Cardiomyopathy: BNP | 12 months | Cardiac biomarkers (BNP, Troponin I) were assessed at baseline, 6 and 12 months, with change at end of study reported |
| Primary | Amyloid Cardiomyopathy: Troponin I | 12 months | Cardiac biomarkers (BNP, Troponin I) were assessed at baseline, 6 and 12 months, with change at change at end of study reported |
| Primary | Amyloid Nephropathy: Creatinine Clearance | 12 months | Creatinine clearance (ml/min) and proteinuria (g/day) were assessed at baseline, 6 and 12 months, with change at change at end of study reported |
| Primary | Amyloid Nephropathy: Proteinuria | Data were assessed at baseline, 6 and 12 months, with change at end of study reported | Patients with predominant amyloid kidney involvement at enrollment. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Amyloid Cardiomyopathy: BNP | 12 months | Analysis is limited to the patients with predominant amyloid heart involvement at enrollment. Mixed models analyses of change from baseline levels of cardiac biomarkers (BNP, Troponin I) were performed to include all collected data. | pg/mL | MEAN |
| PRIMARY | Amyloid Cardiomyopathy: Troponin I | 12 months | Patients with predominant amyloid involvement of the heart. | ng/mL | MEAN |
| PRIMARY | Amyloid Nephropathy: Creatinine Clearance | 12 months | Analysis is limited to the patients with predominant amyloid kidney involvement at enrollment. Mixed models analyses of change from baseline levels of creatinine clearance (ml/min) and proteinuria (g/day) were performed to include all collected data. | ml/min | MEAN |
| PRIMARY | Amyloid Nephropathy: Proteinuria | Data were assessed at baseline, 6 and 12 months, with change at end of study reported | Analysis is limited to the patients with predominant amyloid kidney involvement at enrollment. Mixed models analyses of change from baseline levels of creatinine clearance (ml/min) and proteinuria (g/day) were performed to include all data collected at baseline, 6 and 12 months. | g/day | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Amyloid Cardiomyopathy: BNP | Cardiomyopathy | 883 | Standard Deviation 703 | pg/mL | |
| Amyloid Cardiomyopathy: Troponin I | Cardiomyopathy | 0.15 | Standard Deviation 0.07 | ng/mL | |
| Amyloid Nephropathy: Creatinine Clearance | Amyloid Nephropathy | 82.4 | Standard Deviation 48.0 | ml/min | |
| Amyloid Nephropathy: Proteinuria | Amyloid Nephropathy: Proteinuria (g/Day) | 5.91 | Standard Deviation 3.85 | g/day |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Doxycycline 100 mg po Bid x 12 Months | 25 | |
| Overall Study | COMPLETED | Doxycycline 100 mg po Bid x 12 Months | 14 | |
| Overall Study | NOT COMPLETED | Doxycycline 100 mg po Bid x 12 Months | 11 |
Source ClinicalTrials.gov
Adverse events15
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Skin disruption | Skin and subcutaneous tissue disorders | Doxycycline 100 mg po Bid x 12 Months | 15 | 25 | 21 |
| other | GI disorder | Gastrointestinal disorders | Doxycycline 100 mg po Bid x 12 Months | 9 | 25 | 18 |
| other | Infection | Infections and infestations | Doxycycline 100 mg po Bid x 12 Months | 5 | 25 | 8 |
| serious | Fluid overload | Cardiac disorders | Doxycycline 100 mg po Bid x 12 Months | 3 | 25 | 4 |
| serious | Sun hypersensitivity | Skin and subcutaneous tissue disorders | Doxycycline 100 mg po Bid x 12 Months | 1 | 25 | 1 |
| serious | Bloating | Gastrointestinal disorders | Doxycycline 100 mg po Bid x 12 Months | 1 | 25 | 1 |
| serious | Urinary retention | Renal and urinary disorders | Doxycycline 100 mg po Bid x 12 Months | 1 | 25 | 1 |
| serious | osteonecrosis | Blood and lymphatic system disorders | Doxycycline 100 mg po Bid x 12 Months | 1 | 25 | 1 |
| serious | Orthopedic issues | Surgical and medical procedures | Doxycycline 100 mg po Bid x 12 Months | 2 | 25 | 2 |
| serious | Deep vein thrombosis | Blood and lymphatic system disorders | Doxycycline 100 mg po Bid x 12 Months | 1 | 25 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Doxycycline 100 mg po Bid x 12 Months | 0 | 25 |
| Total, other adverse events | Doxycycline 100 mg po Bid x 12 Months | 21 | 25 |
| Total, serious adverse events | Doxycycline 100 mg po Bid x 12 Months | 12 | 25 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01677286
GET https://conductscience.org/api/trials/v1/NCT01677286/registered