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

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

January 31, 2017

Study Completion Date

January 31, 2017

Conditions
HeadacheCognitive DisturbanceSkin HyperpigmentationArthralgia
Interventions
DRUG

Calcium DTPA

"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."

DRUG

Zinc DTPA

"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."

Trial Locations (1)

27599

UNC Hospitals, Chapel Hill

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Hameln Pharma GmbH

UNKNOWN

lead

University of North Carolina, Chapel Hill

OTHER