A Phase 1, Open-Label Study to Investigate the Dosimetry of Tc-99m-Tilmanocept Following a Single Intravenous Dose Administration in Women and Men Suspected of Diabetic Nephropathy.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Standard uptake value in the kidney
研究概览
简要总结
This proposal will use kidney SPECT/CT of Tc-99m-tilmanocept to evaluate the mesangial changes seen in diabetics across the spectrum of kidney disease as well as persons with hypertensive kidney disease, the next most common cause of kidney disease in patients with diabetes. We aim to demonstrate that these different disease types and stages can be differentiated with Tc-99m-tilmanocept SPECT/CT and can thus be used for future trials evaluating early diagnosis and treatment of diabetic nephropathy.
详细描述
In this open-label, non-randomized, single center study all subjects will receive IV administration of one of 3 tilmanocept mass doses: 0.050 mg, 0.20 mg, and 0.40 mg all radiolabeled with 10 mCi technetium Tc-99m. A total of 120 subjects will be enrolled in this study. 30 subjects in each group will be recruited (total 120). Within each study group, 10 subjects will receive one of the 3 doses mentioned above.
We will start with the lowest molar dose (0.050 mg tilmanocept). Within this dose level we will first study ten patients with normal renal function (Group 1), followed by ten Group 2 patients, ten Group 3 patients, and ten Group 4 patients. This sequence will be repeated at the middle dose level (0.20 mg tilmanocept), and finally at the highest dose (0.40 mg tilmanocept).
Group 1 No evidence of CKD: Participants in this group must have an eGFR >60/ml/min/1.73m2 and a urine albumin to creatinine ratio of <30 mg/g at the time of enrollment.
Group 2 Stage 3a CKD: Participants in this must an eGFR of 45 - 60 /ml/min/1.73m2 Group 3 Stage 3b CKD: Participants in this must an eGFR of 30 - <45 /ml/min/1.73m2 Group 4 Stage 4 CKD: Participants in this must an eGFR of 15 - <30 /ml/min/1.73m2 Participants within each group will be recruited in a 1:1 fashion, of diabetic vs non diabetic, such that within each group, there will be 30 participants, 15 with diabetes and 15 without diabetes. Diabetes will be defined as a history of a hemoglobin A1c >6.5 and an on at least 1 anti-hyperglycemic agent.
In this study subjects will be asked to come in for 4 visits: A screening visit for initial determination of eligibility and evaluation of clinical status (Visit 1), a baseline visit, Day 1 (Visit 2), on the day of tilmanocept administration and imaging, a visit one day after tilmanocept administration Day 2 (Visit 3), and a 5 -7 day safety follow-up (Visit 4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be required to satisfy the following criteria at the screening visit unless otherwise stated:
- •The patient has provided written informed consent with HIPAA (Health Insurance Portability and Accountability Act) authorization before the initiation of any study-related procedures.
- •The patient is at least 18 years of age at the time of consent.
- •The patient has an ECOG performance status of Grade 0 - 2
- •If of childbearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.
- •Subjects will have a BMI of 18 to 49.9 kg/m2, inclusive, at screening.
- •Meets clinical criteria described in the groups section above.
排除标准
- •Subjects who meet any of the following criteria will be excluded from the study.
- •The patient is pregnant or lactating.
- •The patient has participated in another investigational drug study within 3 months prior to Day
- •The subject has another significant medical condition requiring active surgical or medical intervention whose urgency would preclude participation in this study (active cardiac or pulmonary conditions,; ongoing ischemia or cardiac symptoms, uncorrected CAD or decompensated CHF).
- •The subject has a Hemoglobin A1c>10.0
- •The subject is on greater than 4 anti-hypertensives or has a a systolic blood pressure at time of screening greater than 160mm Hg.
- •The patient has a suspected glomerulonephirtis, not including diabetic nephropathy, or hypertensive nephrosclerosis.
- •The subject has a history of significant hypersensitivity, intolerance, or allergy to dextran or modified forms of dextran; unless approved by the Investigator.
- •The subject has a history or presence of an acutely abnormal ECG, which, in the Investigator's opinion, is clinically significant.
- •The subject has exceeded yearly radioactive dose of 30 mSv.
- •The subject has a history of drug abuse or alcohol within 2 years before dose administration.
- •The subjects used any prescription medications within 14 days prior to Day 1, except as allowed by the inclusion criteria or as deemed acceptable by the Investigator.
- •The subject has poor peripheral venous access.
- •The subject has donated blood within 30 days prior to Day 1, or plasma within 2 weeks prior to Day
- •The subject has received blood products within 2 months prior to Day
- •The subject has received any radiopharmaceutical within 7 days prior to the administration of Tc 99m tilmanocept.
研究组 & 干预措施
Tilmanocept Dose - 0.40 mg
干预措施: Tc-99m-Tilmanocept (Diagnostic Test)
Tilmanocept Dose - 0.050 mg
干预措施: Tc-99m-Tilmanocept (Diagnostic Test)
Tilmanocept Dose - 0.20 mg
干预措施: Tc-99m-Tilmanocept (Diagnostic Test)
结局指标
主要结局
Standard uptake value in the kidney
时间窗: Approximately 1 hour
Time until 90% uptake in the kidney measured by SPECT/CT immediately after tilmanocept injection.
次要结局
未报告次要终点
研究者
Carl Hoh
Prof-hcomp - Radiology
University of California, San Diego