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

Stopped early · Phase 1/Phase 2

Conditions studied: Headache, Cognitive Disturbance, Skin Hyperpigmentation, Arthralgia

In brief

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.

Key facts

Study ID

NCT02947022

Run by

University of North Carolina, Chapel Hill

People needed

1

Starts

2016-10-01

Expected to finish

2017-01-31

Last updated by the study team

2018-04-06

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• UNC Hospitals — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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