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

University of North Carolina (UNC)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Skin Hyperpigmentation; Cognitive Disturbance; Arthralgia; Headache

Treatments: Drug: Calcium DTPA; Drug: Zinc DTPA

Study type: Interventional

Funder types: Other

Identifiers

NCT02947022

16-1080

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Calcium DTPA followed by Zinc DTPA

Experimental group

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.

Treatment:

Drug: Zinc DTPA

Drug: Calcium DTPA