Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285298
Status:
COMPLETED
Last Update Posted:
2011-07-29
First Post:
2006-01-31
Brief Title:
Pentoxifylline and Progression of Chronic Kidney Disease in Moderate-to-high Risk Patients
Sponsor:
Walter Reed Army Medical Center
Organization:
Walter Reed Army Medical Center
Study Overview
Official Title:
Pentoxifylline and Progression of Chronic Kidney Disease in Moderate-to-high Risk Patients a Pilot Randomized Placebo-controlled Double-blind Trial
Status:
COMPLETED
Status Verified Date:
2009-09
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:
The purpose of the investigators study is to assess the impact of therapy with Pentoxifylline PTF a nonspecific phosphodiesterase inhibitor on kidney function in patients at high-risk for progression to end-stage renal disease The investigators hypothesize that therapy with Pentoxifylline will slow progression of kidney disease over time
Detailed Description:
The treatment objective for chronic kidney disease CKD regardless of etiology is to slow or halt progression of renal dysfunction and reduce proteinuria in those patients with proteinuric renal disease Multi-drug medical regimens remain the cornerstone of therapy for medical-renal disease often with an angiotensin converting enzyme inhibitor andor an angiotensin receptor blocker These therapies though often efficacious have not been shown to halt disease progression entirely and the medical therapy of renal disease remains suboptimal
PTF is a safe generally well-tolerated drug currently indicated for symptomatic and functional relief of intermittent claudication presumed due to chronic occlusive arterial disease of the limbs A number of small studies in patients across a range of renal disease states show that PTF can reduce proteinuria an important component of treatment of CKD It is not known however if the drug will slow progression of CKD as measured by glomerular filtration rate
Comparisons subjects randomized to receive PTF compared with those randomized to receive placebo
PTF is a safe generally well-tolerated drug currently indicated for symptomatic and functional relief of intermittent claudication presumed due to chronic occlusive arterial disease of the limbs A number of small studies in patients across a range of renal disease states show that PTF can reduce proteinuria an important component of treatment of CKD It is not known however if the drug will slow progression of CKD as measured by glomerular filtration rate
Comparisons subjects randomized to receive PTF compared with those randomized to receive placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11010A NKF | None | None | None |