Who is sponsoring NCT02947022?

NCT02947022 is sponsored by University of North Carolina, Chapel Hill.

What condition does NCT02947022 study?

NCT02947022 studies Headache, Cognitive Disturbance, Skin Hyperpigmentation, Arthralgia.

What drugs are being tested in NCT02947022?

Interventions: Calcium DTPA, Zinc DTPA.

What is the status of NCT02947022?

NCT02947022 is currently TERMINATED.

Last reviewed 2018-04-05 · How we verify

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

NCT02947022 Phase 1/Phase 2 TERMINATED Results posted

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.

Details

Lead sponsor	University of North Carolina, Chapel Hill
Phase	Phase 1/Phase 2
Status	TERMINATED
Enrolment	1
Start date	2016-10
Completion	2017-01-31

Conditions

Headache
Cognitive Disturbance
Skin Hyperpigmentation
Arthralgia

Interventions

Calcium DTPA
Zinc DTPA

Primary outcomes

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

Countries

United States