Trial Outcomes & Findings for Effects of IV-Administered Ca-DTPA and Zn-DTPA To Treat Patients With Gadolinium Deposition Disease (NCT NCT02947022)
NCT ID: NCT02947022
Last Updated: 2018-04-06
Results Overview
TERMINATED
PHASE1/PHASE2
1 participants
Baseline, Month 1
2018-04-06
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Study Stopped
|
1
|
Baseline Characteristics
Effects of IV-Administered Ca-DTPA and Zn-DTPA To Treat Patients With Gadolinium Deposition Disease
Baseline characteristics by cohort
| Measure |
Calcium DTPA Followed by Zinc DTPA
n=1 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 1Population: Data were not analyzed because this study was stopped prematurely.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Month 1Population: Data were not analyzed because this study was stopped prematurely.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 2Population: Data were not analyzed because this study was stopped prematurely.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 2Population: Data were not analyzed because this study was stopped prematurely.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Data were not analyzed because this study was stopped prematurely.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Data were not analyzed because this study was stopped prematurely.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 1 (Day 7)Population: Data were not analyzed because this study was stopped prematurely.
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".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 2 (Day 7)Population: Data were not analyzed because this study was stopped prematurely.
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".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 3 (Day 7)Population: Data were not analyzed because this study was stopped prematurely.
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".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Data were not analyzed because this study was stopped prematurely.
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".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Data were not analyzed because this study was stopped prematurely.
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".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 1 (day 7)Population: Data were not analyzed because this study was stopped prematurely.
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".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 2 (day 7)Population: Data were not analyzed because this study was stopped prematurely.
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".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 3 (day 7)Population: Data were not analyzed because this study was stopped prematurely.
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".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Data were not analyzed because this study was stopped prematurely.
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".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Data were not analyzed because this study was stopped prematurely.
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".
Outcome measures
Outcome data not reported
Adverse Events
Calcium DTPA Followed by Zinc DTPA
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Research Manager
UNC Chapel Hill, Department of Radiology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place