Ignite Creation Date:
2024-07-17 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489340
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-18
Brief Title:
P2a Open Label Study to Evaluate 2-HPβCD in Subjects With Diabetic Kidney Disease
Sponsor:
ZyVersa Therapeutics Inc
Organization:
ZyVersa Therapeutics Inc
Study Overview
Official Title:
A Phase 2a Open Label Study to Evaluate Cholesterol Efflux Mediator VAR200 2- Hydroxypropyl-β-cyclodextrin 2-HPβCD in Subjects With Type 2 Diabetic Kidney Disease DKD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open label two to three center study to evaluate the clinical efficacy and safety of 1 dose level of 2-hydroxypropyl-β-cyclodextrin 2-HPβCD given intravenously in adult patients with type 2 diabetes with diabetic kidney disease DKD and proteinuria
Detailed Description:
This is a Phase 2a open label two to three center study to evaluate the clinical efficacy and safety of 1 dose level of 2-hydroxypropyl-β-cyclodextrin 2-HPβCD given intravenously in adult patients with type 2 diabetes with diabetic kidney disease DKD and proteinuria
The study will be conducted at 2 - 3 sites in the United States of America USA and will screen a sufficient number of subjects to complete 8 participants meeting the inclusionexclusion criteria outlined
The study consists of up to a 2-week screening period a 12-week treatment period and a 4-week follow-up period
The study will be conducted at 2 - 3 sites in the United States of America USA and will screen a sufficient number of subjects to complete 8 participants meeting the inclusionexclusion criteria outlined
The study consists of up to a 2-week screening period a 12-week treatment period and a 4-week follow-up period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None