Ignite Creation Date:
2024-05-06 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03630029
Status:
WITHDRAWN
Last Update Posted:
2020-05-11
First Post:
2018-08-07
Brief Title:
RBT-1 Phase 1b Clinical Trial in Healthy Volunteers and Subjects With CKD
Sponsor:
Renibus Therapeutics Inc
Organization:
Renibus Therapeutics Inc
Study Overview
Official Title:
A Phase 1b Dose-escalating Study With RBT-1 in Healthy Volunteers and Subjects With Chronic Kidney Disease Stage 3b-4
Status:
WITHDRAWN
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The trial has been enhanced a new NCTNCT03893799 listing was created
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase 1b study to evaluate the safety tolerability and pharmacodynamic effect of RBT-1 in healthy volunteers and subjects with stage 3b-4 CKD
Detailed Description:
This is a Phase 1b single-center dose-escalating study to evaluate the safety tolerability and pharmacodynamic effect of RBT-1 in healthy volunteers and in subjects with stage 3b-4 CKD The following biomarkers will be used as surrogate measures of protective activity Haptoglobin Ferritin Bilirubin Hemopexin IL-10 and Heme Oxygenase-1 Additionally the P21 biomarker will be monitored at various points of the study
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