Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

RECRUITING

Dosimetry of Tc-99m-Tilmanocept

Lead Sponsor:

University of California, San Diego

Conditions:

Diabetic Kidney Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

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 disea...

Detailed Description

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 tech...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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 1.
  • 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 1.
  • The subject has received blood products within 2 months prior to Day 1.
  • The subject has received any radiopharmaceutical within 7 days prior to the administration of Tc 99m tilmanocept.

Key Trial Info

Start Date :

August 6 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2024

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT05241522

Start Date

August 6 2021

End Date

December 31 2024

Last Update

May 7 2024

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

UC San Diego Medical Center

San Diego, California, United States, 92103