Evaluating kidney changes in diabetic patients using a specific imaging agent

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.

This study is testing a special imaging agent to see if it can help doctors tell the difference between kidney problems caused by diabetes and those caused by high blood pressure in people with kidney disease.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, San Diego (other)
• Locations: 1 site (San Diego, California)
• Trial ID: NCT05241522 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of Tc-99m-tilmanocept in differentiating mesangial changes in patients with diabetic kidney disease and hypertensive kidney disease through kidney SPECT/CT imaging. It will involve 120 participants divided into four groups based on their kidney function and diabetes status, receiving varying doses of the imaging agent. The goal is to establish a method for early diagnosis and treatment of diabetic nephropathy by identifying distinct disease types and stages.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with varying stages of chronic kidney disease, both diabetic and non-diabetic.

Not a fit: Patients who are pregnant, lactating, or have severe kidney impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved early diagnosis and treatment strategies for diabetic kidney disease.

How similar studies have performed: While this approach is novel, similar imaging techniques have shown promise in other studies for assessing kidney conditions.

Eligibility criteria

Inclusion Criteria:

* Subjects will be required to satisfy the following criteria at the screening visit unless otherwise stated:

  1. The patient has provided written informed consent with HIPAA (Health Insurance Portability and Accountability Act) authorization before the initiation of any study-related procedures.
  2. The patient is at least 18 years of age at the time of consent.
  3. The patient has an ECOG performance status of Grade 0 - 2
  4. 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.
  5. Subjects will have a BMI of 18 to 49.9 kg/m2, inclusive, at screening.
  6. Meets clinical criteria described in the groups section above.

Exclusion Criteria:

* Subjects who meet any of the following criteria will be excluded from the study.

  1. The patient is pregnant or lactating.
  2. The patient has participated in another investigational drug study within 3 months prior to Day 1.
  3. 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).
  4. The subject has a Hemoglobin A1c\>10.0
  5. The subject is on greater than 4 anti-hypertensives or has a a systolic blood pressure at time of screening greater than 160mm Hg.
  6. The patient has a suspected glomerulonephirtis, not including diabetic nephropathy, or hypertensive nephrosclerosis.
  7. The subject has a history of significant hypersensitivity, intolerance, or allergy to dextran or modified forms of dextran; unless approved by the Investigator.
  8. The subject has a history or presence of an acutely abnormal ECG, which, in the Investigator's opinion, is clinically significant.
  9. The subject has exceeded yearly radioactive dose of 30 mSv.
  10. The subject has a history of drug abuse or alcohol within 2 years before dose administration.
  11. 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.
  12. The subject has poor peripheral venous access.
  13. The subject has donated blood within 30 days prior to Day 1, or plasma within 2 weeks prior to Day 1.
  14. The subject has received blood products within 2 months prior to Day 1.
  15. The subject has received any radiopharmaceutical within 7 days prior to the administration of Tc 99m tilmanocept.

Where this trial is running

San Diego, California

• UC San Diego Medical Center — San Diego, California, United States (RECRUITING)

Study contacts

• Principal investigator: Carl Hoh, MD — UC San Diego Medical Center
• Study coordinator: Carl Hoh, MD

Conditions: Diabetic Kidney Disease