Ignite Creation Date:
2024-07-17 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475274
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-20
Brief Title:
A Phase 2b Dose Finding Study of RMC-035 in Participants Undergoing Open-chest Cardiac Surgery
Sponsor:
Guard Therapeutics AB
Organization:
Guard Therapeutics AB
Study Overview
Official Title:
A Phase 2b Randomized Placebo-Controlled Double-Blind Parallel Group Dose-Finding Study to Evaluate the Efficacy on Renal Function and Safety of RMC-035 in Participants At High Risk for Kidney Injury Following Open-Chest Cardiac Surgery
Status:
RECRUITING
Status Verified Date:
2024-10
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:
POINTER
Brief Summary:
The goal of this clinical trial is to identify the optimal dose of RMC-035 for protection of long-term renal function in adult patients undergoing cardiac surgery who are at high risk of kidney injury It will also learn about the safety of RMC-035 The main question it aims to answer is
Does RMC-035 protect the function of kidneys after surgery
Is RMC-035 safe
Researchers will compare RMC-035 in high dose RMC-035 in low dose and placebo to see if
Kidney function better for participants treated with any of the RMC-035 doses
What medical problems do participants have when receiving RMC-035
Participants will
Receive 3 doses of RMC-035 or placebo at the beginning of surgery end of surgery and 24h after surgery
Have extra checkups and tests during their hospital stay
Visit the clinic at two extra occasions at 60 days and 90 days after surgery for checkups and tests
Does RMC-035 protect the function of kidneys after surgery
Is RMC-035 safe
Researchers will compare RMC-035 in high dose RMC-035 in low dose and placebo to see if
Kidney function better for participants treated with any of the RMC-035 doses
What medical problems do participants have when receiving RMC-035
Participants will
Receive 3 doses of RMC-035 or placebo at the beginning of surgery end of surgery and 24h after surgery
Have extra checkups and tests during their hospital stay
Visit the clinic at two extra occasions at 60 days and 90 days after surgery for checkups and tests
Detailed Description:
None
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