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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
Sponsor:
Collaborator:
Hameln Pharma GmbH
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Headache Cognitive Disturbance Skin Hyperpigmentation Arthralgia Drug: Calcium DTPA Drug: Zinc DTPA Phase 1 Phase 2

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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




Primary Outcome Measures :
  1. Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration. [ Time Frame: Baseline, Month 1 ]
  2. 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 Measures :
  1. Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration. [ Time Frame: Baseline, Month 2 ]
  2. Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration. [ Time Frame: Baseline, Month 2 ]
  3. Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration. [ Time Frame: Baseline, Month 3 ]
  4. Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration. [ Time Frame: Baseline, Month 3 ]
  5. 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".

  6. 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".

  7. 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".

  8. 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".

  9. 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".

  10. 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".

  11. 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".

  12. 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".

  13. 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".

  14. 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".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, North Carolina
UNC Hospitals
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Hameln Pharma GmbH
Investigators
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Principal Investigator: Richard Semelka, MD University of North Carolina, Chapel Hill
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:
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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
Keywords provided by University of North Carolina, Chapel Hill:
gadolinium
deposition
GBCA
Extremity Pain
Skin Pain
Chest Wall Pain
Additional relevant MeSH terms:
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Arthralgia
Hyperpigmentation
Headache
Cognitive Dysfunction
Pain
Neurologic Manifestations
Signs and Symptoms
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
Nutrients
Growth Substances
Antidotes
Protective Agents
Chelating Agents
Sequestering Agents