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

NCT02947022 | Terminated Phase 1 Results DMC

• 1 other identifier: 16-1080
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache; Cognitive Disturbance; Skin Hyperpigmentation; Arthralgia

Keywords

gadolinium; deposition; GBCA; Extremity Pain; Skin Pain; Chest Wall Pain

Outcome Measures

Primary Outcomes (2)

• Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.

  Baseline, Month 1

• Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.

  Baseline, Month 1

Secondary Outcomes (14)

• Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.

  Baseline, Month 2

• Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.

  Baseline, Month 2

• Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.

  Baseline, Month 3

• Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.

  Baseline, Month 3

• Change From Baseline to Month 1 in the Pain Score

  Baseline, Month 1 (Day 7)

Study Arms (1)

Calcium DTPA followed by Zinc DTPA

EXPERIMENTAL

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; Drug: Zinc DTPA

Interventions

Calcium DTPA DRUG

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.

Also known as: Pentetate calcium trisodium injection

Calcium DTPA followed by Zinc DTPA

Zinc DTPA DRUG

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.

Also known as: Pentetate zinc trisodium injection

Calcium DTPA followed by Zinc DTPA

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cognitive disturbance
• Extremity pain
• Headache
• Chest wall pain
• Skin induration
• Skin hyperpigmentation
• Skin pain
• Arthralgia

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Hameln Pharma GmbH: collaborator

Study Sites (1)

UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Headache; Cognition Disorders; Hyperpigmentation; Arthralgia

Interventions

Pentetic Acid

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Limitations and Caveats

The study was stopped on 1/31/16. Only 1 patient received 1 treatment prior to the study stopping.

Results Point of Contact

• Title: Clinical Research Manager
• Organization: UNC Chapel Hill, Department of Radiology

rad_research@med.unc.edu

919-966-4997

Study Officials

• Richard Semelka, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 27, 2016
• Study Start: October 1, 2016
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: April 6, 2018
• Results First Posted: April 6, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)