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
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Exhibiting 3 or greater of the following symptoms which must be present after having been administered a GBCA:
- •Cognitive disturbance
- •Extremity pain
- •Chest wall pain
- •Skin induration
- •Skin hyperpigmentation
- •Skin pain
- •Arthralgia
排除标准
- •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
研究组 & 干预措施
Calcium DTPA followed by Zinc DTPA
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.
干预措施: Calcium DTPA (Drug)
Calcium DTPA followed by Zinc DTPA
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.
干预措施: Zinc DTPA (Drug)
结局指标
主要结局
Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.
时间窗: Baseline, Month 1
Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.
时间窗: Baseline, Month 1
次要结局
- Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.(Baseline, Month 3)
- Change in ACPA QOL Score at Month 12(Baseline, Month 12)
- 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 the Pain Score(Baseline, Month 2 (Day 7))
- Change From Baseline to Month 3 in the Pain Score(Baseline, Month 3 (Day 7))
- Change From Baseline to Month 6 in the Pain Score(Baseline, Month 6)
- Change in ACPA QOL Score From Baseline to Month 2(Baseline, Month 2 (day 7))
- Change in ACPA QOL Score at Month 3(Baseline, Month 3 (day 7))
- 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 1 in the Pain Score(Baseline, Month 1 (Day 7))
- Change in American Chronic Pain Association (ACPA) Quality of Life (QOL) Score From Baseline to Month 1(Baseline, Month 1 (day 7))
- Change From Baseline to Month 12 in the Pain Score(Baseline, Month 12)
- Change in ACPA QOL Score at Month 6(Baseline, Month 6)