Clinical trial NCT02947022: Effects of IV-Administered Ca-DTPA and Zn-DTPA To Treat Patients With Gadolinium Deposition Disease
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Headache
Cognitive Disturbance
Skin Hyperpigmentation
Arthralgia
Keywords: gadolinium
deposition
GBCA
Extremity Pain
Skin Pain
Chest Wall Pain
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Hameln Pharma GmbH
First posted: 2016-10-27
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
timeFrame: Baseline, Month 1
measure: Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
timeFrame: Baseline, Month 1
Secondary outcomes:
measure: Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
timeFrame: Baseline, Month 2
measure: Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
timeFrame: Baseline, Month 2
measure: Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
timeFrame: Baseline, Month 3
measure: Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
timeFrame: Baseline, Month 3
measure: Change From Baseline to Month 1 in the Pain Score
timeFrame: Baseline, Month 1 (Day 7)
measure: Change From Baseline to Month 2 in the Pain Score
timeFrame: Baseline, Month 2 (Day 7)
measure: Change From Baseline to Month 3 in the Pain Score
timeFrame: Baseline, Month 3 (Day 7)
measure: Change From Baseline to Month 6 in the Pain Score
timeFrame: Baseline, Month 6
measure: Change From Baseline to Month 12 in the Pain Score
timeFrame: Baseline, Month 12
measure: Change in American Chronic Pain Association (ACPA) Quality of Life (QOL) Score From Baseline to Month 1
timeFrame: Baseline, Month 1 (day 7)
measure: Change in ACPA QOL Score From Baseline to Month 2
timeFrame: Baseline, Month 2 (day 7)
measure: Change in ACPA QOL Score at Month 3
timeFrame: Baseline, Month 3 (day 7)
measure: Change in ACPA QOL Score at Month 6
timeFrame: Baseline, Month 6
measure: Change in ACPA QOL Score at Month 12
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Richard Semelka, MD
role: PRINCIPAL_INVESTIGATOR
References: