Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004496
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients With Acute Renal Failure
Sponsor:
University of Texas
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-08
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:
OBJECTIVES I Determine the maximum tolerated dose and safety of alpha-melanocyte stimulating hormone alpha-MSH in patients with acute renal failure
II Determine the safety and pharmacokinetics of alpha-MSH in patients at high risk of acute renal failure after renal transplantation
III Determine the safety and pharmacokinetics of alpha-MSH in patients with established ischemic acute renal failure
IV Determine the effect of alpha-MSH on interleukin-10 pharmacokinetics
II Determine the safety and pharmacokinetics of alpha-MSH in patients at high risk of acute renal failure after renal transplantation
III Determine the safety and pharmacokinetics of alpha-MSH in patients with established ischemic acute renal failure
IV Determine the effect of alpha-MSH on interleukin-10 pharmacokinetics
Detailed Description:
PROTOCOL OUTLINE This is a dose escalation double blind placebo controlled multicenter study
Group 1 Patients are infused with alpha-melanocyte stimulating hormone alpha-MSH or placebo over 5 minutes A cohort of 5 patients is infused at each dose level of alpha-MSH until the minimum effective dose MED and the maximum tolerated dose MTD are determined
Group 2 Patients receive a single dose of the MED of alpha-MSH IV over 5 minutes at the time anastomoses are complete Other patients receive alpha-MSH at the MTD Cohorts of 5 patients each are treated at the MED and the MTD
Group 3 Patients receive alpha-MSH as in group 2 Additional dose levels are also tested
Completion date provided represents the completion date of the grant per OOPD records
Group 1 Patients are infused with alpha-melanocyte stimulating hormone alpha-MSH or placebo over 5 minutes A cohort of 5 patients is infused at each dose level of alpha-MSH until the minimum effective dose MED and the maximum tolerated dose MTD are determined
Group 2 Patients receive a single dose of the MED of alpha-MSH IV over 5 minutes at the time anastomoses are complete Other patients receive alpha-MSH at the MTD Cohorts of 5 patients each are treated at the MED and the MTD
Group 3 Patients receive alpha-MSH as in group 2 Additional dose levels are also tested
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UTSMC-129447100 | None | None | None |
| UTSMC-FDR001552 | None | None | None |