Effects of IV-Administered Ca-DTPA and Zn-DTPA To Treat Patients With Gadolinium Deposition Disease

Phase 1

Terminated

Conditions: Headache
Arthralgia
Cognitive Disturbance
Skin Hyperpigmentation

Interventions: Drug: Calcium DTPA
Drug: Zinc DTPA

Registration Number: NCT02947022

Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Calcium DTPA followed by Zinc DTPA	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 followed by Zinc DTPA	Calcium 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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.	Baseline, Month 1
Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.	Baseline, Month 1

Secondary Outcome Measures

Name	Time	Method
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 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 Zinc DTPA Administration.	Baseline, Month 2
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 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 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 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 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 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 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 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".