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

Primary Purpose

Headache, Cognitive Disturbance, Skin Hyperpigmentation

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Calcium DTPA
Zinc DTPA
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache focused on measuring gadolinium, deposition, GBCA, Extremity Pain, Skin Pain, Chest Wall Pain

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UNC Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Calcium DTPA followed by Zinc DTPA

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
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".
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".
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".
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".
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".
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".
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".
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".
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".
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".

Full Information

First Posted
October 25, 2016
Last Updated
April 5, 2018
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Hameln Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02947022
Brief Title
Effects of IV-Administered Ca-DTPA and Zn-DTPA To Treat Patients With Gadolinium Deposition Disease
Official Title
Investigator Initiated Investigational New Drug Application to Study the Effects of IV-Administered Ca-DTPA and Zn-DTPA To Treat Patients With Gadolinium Deposition Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
PI left institution.
Study Start Date
October 2016 (undefined)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
January 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Hameln Pharma GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Cognitive Disturbance, Skin Hyperpigmentation, Arthralgia
Keywords
gadolinium, deposition, GBCA, Extremity Pain, Skin Pain, Chest Wall Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcium DTPA followed by Zinc DTPA
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Calcium DTPA
Other Intervention Name(s)
Pentetate calcium trisodium injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Zinc DTPA
Other Intervention Name(s)
Pentetate zinc trisodium injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
Time Frame
Baseline, Month 1
Title
Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
Time Frame
Baseline, Month 1
Secondary Outcome Measure Information:
Title
Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
Time Frame
Baseline, Month 2
Title
Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
Time Frame
Baseline, Month 2
Title
Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
Time Frame
Baseline, Month 3
Title
Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
Time Frame
Baseline, Month 3
Title
Change From Baseline to Month 1 in the Pain Score
Description
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)
Title
Change From Baseline to Month 2 in the Pain Score
Description
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)
Title
Change From Baseline to Month 3 in the Pain Score
Description
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)
Title
Change From Baseline to Month 6 in the Pain Score
Description
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
Title
Change From Baseline to Month 12 in the Pain Score
Description
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
Title
Change in American Chronic Pain Association (ACPA) Quality of Life (QOL) Score From Baseline to Month 1
Description
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)
Title
Change in ACPA QOL Score From Baseline to Month 2
Description
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)
Title
Change in ACPA QOL Score at Month 3
Description
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)
Title
Change in ACPA QOL Score at Month 6
Description
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
Title
Change in ACPA QOL Score at Month 12
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Semelka, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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