Effects of IV-Administered Ca-DTPA and Zn-DTPA To Treat Patients With Gadolinium Deposition Disease
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02947022 |
Recruitment Status :
Terminated
(PI left institution.)
First Posted : October 27, 2016
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Headache Cognitive Disturbance Skin Hyperpigmentation Arthralgia | Drug: Calcium DTPA Drug: Zinc DTPA | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | October 2016 |
Actual Primary Completion Date : | January 31, 2017 |
Actual Study Completion Date : | January 31, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
|
Drug: 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 month apart. Other Name: Pentetate calcium trisodium injection Drug: Zinc 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. Other Name: Pentetate zinc trisodium injection |
- Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration. [ Time Frame: Baseline, Month 1 ]
- Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration. [ Time Frame: Baseline, Month 1 ]
- Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration. [ Time Frame: Baseline, Month 2 ]
- Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration. [ Time Frame: Baseline, Month 2 ]
- Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration. [ Time Frame: Baseline, Month 3 ]
- Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration. [ Time Frame: Baseline, Month 3 ]
- Change From Baseline to Month 1 in the Pain Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 12 in the Pain Score [ Time Frame: 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 American Chronic Pain Association (ACPA) Quality of Life (QOL) Score From Baseline to Month 1 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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".

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947022
United States, North Carolina | |
UNC Hospitals | |
Chapel Hill, North Carolina, United States, 27599 |
Principal Investigator: | Richard Semelka, MD | University of North Carolina, Chapel Hill |
Documents provided by University of North Carolina, Chapel Hill:
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT02947022 |
Other Study ID Numbers: |
16-1080 |
First Posted: | October 27, 2016 Key Record Dates |
Results First Posted: | April 6, 2018 |
Last Update Posted: | April 6, 2018 |
Last Verified: | February 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
gadolinium deposition GBCA |
Extremity Pain Skin Pain Chest Wall Pain |
Arthralgia Hyperpigmentation Headache Cognitive Dysfunction Pain Neurologic Manifestations Joint Diseases Musculoskeletal Diseases Pigmentation Disorders Skin Diseases Cognition Disorders Neurocognitive Disorders Mental Disorders Calcium, Dietary Zinc |
Edetic Acid Calcium Pentetic Acid Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Bone Density Conservation Agents Trace Elements Micronutrients Antidotes Protective Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action Iron Chelating Agents Anticoagulants |