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PI left institution.
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| Name | Class |
|---|---|
| Hameln Pharma GmbH | UNKNOWN |
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Purpose: There are two goals we have for this prospective single arm study; to see an increase in the amount of gadolinium in 24 hour urine collection following each infusion treatment with Calcium and Zinc DTPA, and to see a reduction or elimination of gadolinium deposition disease (GDD) symptoms.
Participants: Twenty (20) patients who are suffering from gadolinium deposition disease (GDD)
Procedures: Over a series of three (3) treatment time-points patients will be treated with IV Ca-DTPA on day one, and Zn-DTPA on day two.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium DTPA followed by Zinc DTPA | Experimental | Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium DTPA | Drug | On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening. The same treatment therapy will consist of 3 time-points, approximately 1 month apart. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration. | Baseline, Month 1 | |
| Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration. | Baseline, Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration. | Baseline, Month 2 | |
| Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration. | Baseline, Month 2 |
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Inclusion Criteria: Exhibiting 3 or greater of the following symptoms which must be present after having been administered a GBCA:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Semelka, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Hospitals | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcium DTPA Followed by Zinc DTPA | Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3. Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening. The same treatment therapy will consist of 3 time-points, approximately 1 m |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One patient was enrolled and treated in the trial. The patient did not have any adequate follow up data for analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Calcium DTPA Followed by Zinc DTPA | Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3. Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening. The same treatment therapy will consist of 3 time-points, approximately 1 m |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration. | Data were not analyzed because this study was stopped prematurely. | Posted | Baseline, Month 1 |
|
Throughout treatment and for 12 days after the last dose (or cessation), an average of 2 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calcium DTPA Followed by Zinc DTPA | Subjects will receive IV administration of Ca-DTPA on Day 1 and Zn-DTPA on Day 2 at each of treatment time-points. Three identical treatment time-points are scheduled on Month 1, Month 2 and Month 3. Calcium DTPA: On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening. The same treatment therapy will consist of 3 time-points, approximately 1 m |
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The study was stopped on 1/31/16. Only 1 patient received 1 treatment prior to the study stopping.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | UNC Chapel Hill, Department of Radiology | 919-966-4997 | rad_research@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2016 | Feb 5, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006261 | Headache |
| D003072 | Cognition Disorders |
| D017495 | Hyperpigmentation |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004369 | Pentetic Acid |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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|
|
| Zinc DTPA | Drug | On Day 2, 2.5 mL of Zn-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Zn-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening. The same treatment therapy will consist of 3 time-points, approximately 1 month apart. |
|
|
| Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration. | Baseline, Month 3 |
| Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration. | Baseline, Month 3 |
| Change From Baseline to Month 1 in the Pain Score | Patient self-reported pain scores assessed using a Visual Analog Scale (VAS) ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain". | Baseline, Month 1 (Day 7) |
| Change From Baseline to Month 2 in the Pain Score | Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain". | Baseline, Month 2 (Day 7) |
| Change From Baseline to Month 3 in the Pain Score | Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain". | Baseline, Month 3 (Day 7) |
| Change From Baseline to Month 6 in the Pain Score | Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain". | Baseline, Month 6 |
| Change From Baseline to Month 12 in the Pain Score | Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain". | Baseline, Month 12 |
| Change in American Chronic Pain Association (ACPA) Quality of Life (QOL) Score From Baseline to Month 1 | The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life". | Baseline, Month 1 (day 7) |
| Change in ACPA QOL Score From Baseline to Month 2 | The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life". | Baseline, Month 2 (day 7) |
| Change in ACPA QOL Score at Month 3 | The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life". | Baseline, Month 3 (day 7) |
| Change in ACPA QOL Score at Month 6 | The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life". | Baseline, Month 6 |
| Change in ACPA QOL Score at Month 12 | The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life". | Baseline, Month 12 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration. | Data were not analyzed because this study was stopped prematurely. | Posted | Baseline, Month 1 |
|
|
| Secondary | Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration. | Data were not analyzed because this study was stopped prematurely. | Posted | Baseline, Month 2 |
|
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| Secondary | Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration. | Data were not analyzed because this study was stopped prematurely. | Posted | Baseline, Month 2 |
|
|
| Secondary | Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration. | Data were not analyzed because this study was stopped prematurely. | Posted | Baseline, Month 3 |
|
|
| Secondary | Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration. | Data were not analyzed because this study was stopped prematurely. | Posted | Baseline, Month 3 |
|
|
| Secondary | Change From Baseline to Month 1 in the Pain Score | Patient self-reported pain scores assessed using a Visual Analog Scale (VAS) ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain". | Data were not analyzed because this study was stopped prematurely. | Posted | Baseline, Month 1 (Day 7) |
|
|
| Secondary | Change From Baseline to Month 2 in the Pain Score | Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain". | Data were not analyzed because this study was stopped prematurely. | Posted | Baseline, Month 2 (Day 7) |
|
|
| Secondary | Change From Baseline to Month 3 in the Pain Score | Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain". | Data were not analyzed because this study was stopped prematurely. | Posted | Baseline, Month 3 (Day 7) |
|
|
| Secondary | Change From Baseline to Month 6 in the Pain Score | Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain". | Data were not analyzed because this study was stopped prematurely. | Posted | Baseline, Month 6 |
|
|
| Secondary | Change From Baseline to Month 12 in the Pain Score | Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates "no pain", 4 through 6 reflect "moderate pain", and 10 reflects "worst possible pain". | Data were not analyzed because this study was stopped prematurely. | Posted | Baseline, Month 12 |
|
|
| Secondary | Change in American Chronic Pain Association (ACPA) Quality of Life (QOL) Score From Baseline to Month 1 | The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life". | Data were not analyzed because this study was stopped prematurely. | Posted | Baseline, Month 1 (day 7) |
|
|
| Secondary | Change in ACPA QOL Score From Baseline to Month 2 | The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life". | Data were not analyzed because this study was stopped prematurely. | Posted | Baseline, Month 2 (day 7) |
|
|
| Secondary | Change in ACPA QOL Score at Month 3 | The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life". | Data were not analyzed because this study was stopped prematurely. | Posted | Baseline, Month 3 (day 7) |
|
|
| Secondary | Change in ACPA QOL Score at Month 6 | The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life". | Data were not analyzed because this study was stopped prematurely. | Posted | Baseline, Month 6 |
|
|
| Secondary | Change in ACPA QOL Score at Month 12 | The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents "Non-functioning" and 10 represents "Normal Quality of Life". | Data were not analyzed because this study was stopped prematurely. | Posted | Baseline, Month 12 |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
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| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |