Viewing Study NCT00456859


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Study NCT ID: NCT00456859
Status: COMPLETED
Last Update Posted: 2007-10-18
First Post: 2007-04-04
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Carbonaceous Oral Adsorbent's Effects on Progression of Chronic Kidney Disease
Sponsor: Institute for Health Outcomes and Process Evaluation Reseach
Organization:

Study Overview

Official Title: Carbonaceous Oral Adsorbent's Effects on Progression of Chronic Kidney Disease (CAP-KD)
Status: COMPLETED
Status Verified Date: 2007-10
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: CAP-KD
Brief Summary: The CAP-KD trial is a prospective, multicenter, randomized, open-label, two-arm, parallel group comparison clinical trial and will be conducted as a researcher-directed study to assess the efficacy of Kremezin in preventing the progression of CKD. We compare two groups of patients: those receiving conventional treatment alone and those receiving such treatment paired with Kremezin.
Detailed Description: A clinical trial to evaluate the efficacy of the oral carbonaceous adsorbent Kremezin in preventing the progression of chronic kidney disease (the Carbonaceous Oral Adsorbent's Effects on Progression of Chronic Kidney Disease \[CAP-KD\] trial) in predialysis patients. In the trial we are comparing two treatments: conventional treatment comprising an ACEI and/or ARB together with a low-protein diet, and combination treatment comprising the conventional treatment paired with Kremezin. Furthermore, we will compare the QOL in both groups of patients

Study Oversight

Has Oversight DMC: True
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?: