Arthralgia, Cognitive Disturbance, Headache, Skin Hyperpigmentation
Conditions
Keywords
gadolinium, deposition, GBCA, Extremity Pain, Skin Pain, Chest Wall Pain
Brief summary
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.
Interventions
DRUGCalcium 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 month apart.
DRUGZinc DTPA
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.
Sponsors
Hameln Pharma GmbH
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Exhibiting 3 or greater of the following symptoms which must be present after having been administered a GBCA: * Cognitive disturbance * Extremity pain * Headache * Chest wall pain * Skin induration * Skin hyperpigmentation * Skin pain * Arthralgia
Exclusion criteria
* Pregnant or lactating * Less than 18 years old * No evidence of gadolinium (has to have shown previous demonstration of Gd by urine analysis or bone biopsy) * Known connective tissue disease such as Systemic Lupus Erythematosus or Scleroderma * Severe hemochromatosis or Wilson's disease * Glomerular Filtration Rate (GFR) ≤ 60 * Have had an investigational drug within last 30 days * Unable to give written consent * Multiple Sclerosis * Chronic heart failure * Cirrhosis of the liver
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, Month 1 (Day 7) | 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. |
| Change From Baseline to Month 2 in the Pain Score | Baseline, Month 2 (Day 7) | 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. |
| Change From Baseline to Month 3 in the Pain Score | Baseline, Month 3 (Day 7) | 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. |
| Change From Baseline to Month 6 in the Pain Score | Baseline, Month 6 | 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. |
| Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration. | Baseline, Month 2 | — |
| Change in American Chronic Pain Association (ACPA) Quality of Life (QOL) Score From Baseline to Month 1 | Baseline, Month 1 (day 7) | 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. |
| Change in ACPA QOL Score From Baseline to Month 2 | Baseline, Month 2 (day 7) | 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. |
| Change in ACPA QOL Score at Month 3 | Baseline, Month 3 (day 7) | 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. |
| Change in ACPA QOL Score at Month 6 | Baseline, 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. |
| Change in ACPA QOL Score at Month 12 | Baseline, 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. |
| Change From Baseline to Month 12 in the Pain Score | Baseline, Month 12 | 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. |
| Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration. | Baseline, Month 2 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study Stopped | 1 |
Baseline characteristics
| Characteristic | Calcium DTPA Followed by Zinc DTPA |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 49 years STANDARD_DEVIATION 0 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
Time frame: Baseline, Month 1
Population: Data were not analyzed because this study was stopped prematurely.
Primary
Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
Time frame: Baseline, Month 1
Population: Data were not analyzed because this study was stopped prematurely.
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.
Time frame: Baseline, Month 12
Population: Data were not analyzed because this study was stopped prematurely.
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.
Time frame: Baseline, Month 1 (Day 7)
Population: Data were not analyzed because this study was stopped prematurely.
Secondary
Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
Time frame: Baseline, Month 2
Population: Data were not analyzed because this study was stopped prematurely.
Secondary
Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
Time frame: Baseline, Month 2
Population: Data were not analyzed because this study was stopped prematurely.
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.
Time frame: Baseline, Month 2 (Day 7)
Population: Data were not analyzed because this study was stopped prematurely.
Secondary
Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
Time frame: Baseline, Month 3
Population: Data were not analyzed because this study was stopped prematurely.
Secondary
Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
Time frame: Baseline, Month 3
Population: Data were not analyzed because this study was stopped prematurely.
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.
Time frame: Baseline, Month 3 (Day 7)
Population: Data were not analyzed because this study was stopped prematurely.
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.
Time frame: Baseline, Month 6
Population: Data were not analyzed because this study was stopped prematurely.
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.
Time frame: Baseline, Month 12
Population: Data were not analyzed because this study was stopped prematurely.
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.
Time frame: Baseline, Month 3 (day 7)
Population: Data were not analyzed because this study was stopped prematurely.
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.
Time frame: Baseline, Month 6
Population: Data were not analyzed because this study was stopped prematurely.
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.
Time frame: Baseline, Month 2 (day 7)
Population: Data were not analyzed because this study was stopped prematurely.
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.
Time frame: Baseline, Month 1 (day 7)
Population: Data were not analyzed because this study was stopped prematurely.