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

• Status: Terminated
• Trial end date: 2017-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Hameln Pharma GmbH
• Treatments: Calcium; Calcium, Dietary; Edetic Acid; Pentetic Acid; Zinc

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