Ignite Creation Date:
2024-05-06 @ 12:01 AM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01475760
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2011-11-17
Brief Title:
A Study to Evaluate Chitosan Chewing Gum in Patients With Chronic Kidney Disease
Sponsor:
Denver Nephrologists PC
Organization:
Denver Nephrologists PC
Study Overview
Official Title:
A Multi-Center Open Label Study to Evaluate Chitosan Chewing Gum in Patients With Chronic Kidney Disease
Status:
COMPLETED
Status Verified Date:
2012-08
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:
The purpose of this study is to determine the efficacy of chitosan chewing gum K2CG in reducing serum phosphorus in subjects with chronic kidney disease
Detailed Description:
Given the public health importance of increased P levels in the general population and specifically in patients with chronic kidney disease it is of great importance to evaluate the ability of a medical food such as K2CG to reduce elevated serum P levels In patients with CKD receiving dialysis it has been estimated that sustained control of serum P may result in an approximate 17 reduction in mortality
The investigators have conducted a previous pilot double blind randomized controlled study of K2CG 20 mg and 40 mg BID for 4 weeks in 90 patients with ESRD In this initial study the investigators did not observe a statistically significant reduction in either serum P or salivary P with active therapy as compared to placebo However a clear trend towards a reduction in serum P was seen in the randomized phase of the study with the active gum administered twice a day During the open-label period where the gum was administered thrice-daily the investigators did see a statistically significant reduction in serum P of 03 mgdL Moreover in patients with CKD not on dialysis the investigators observed a reduction in mean serum P of approximately 02 mgdL While not statistically significant this trial was not powered to detect this level of change in serum P and was underpowered to do so Differences in this range 02-04 mgdL have been reported in studies utilizing dietary manipulation plant protein versus animal protein and with the use of Niacin and are felt to be clinically meaningful reductions
The investigators have previously also conducted a cross-sectional observational study evaluating salivary P levels across a wide spectrum of eGFR The data indicate that mean salivary P is uniformly increased 15-25 mgdL relative to serum P 25- 45 mgdL being approximately 5-7X higher as shown below group 1 eGFR 90 group 7 eGFR 15 Importantly salivary P was similar across the entire spectrum of eGFR
The investigators have previously conducted a clinical trial evaluating several different formulations of K2CG with varying amounts of chitosan loading into the gum base variable weights of gum base and 2 different formulations of gum base In these trials the investigators further studied the effects of gum chewing in either the fasted or fed state and the effects of varying amounts of gum chewing time Results from this study have demonstrated that the maximal amount of P loading into the K2CG is seen with the 1g chewing gum containing 20 mg chitosan and that the maximal effect is seen with 30 minutes of gum chewing
Based on data from this study the investigators have chosen this strengthformulation for the primary efficacy endpoint assessment in the current protocol Similar efficacy results with regard to total P loading per chewing gum were seen with the 20 gram 60 mg chitosan chewing gum and there was an indication that subjects had a subjective preference for this formulation As a result this protocol will also assess as a secondary efficacy endpoint the reduction in serum P with this strengthformulation during an open label phase only in those subjects who have responded during the primary efficacy assessment phase This will allow a comparison of efficacy between the 2 gum sizesstrengths among known responders with regard to serum P reduction
The investigators have conducted a previous pilot double blind randomized controlled study of K2CG 20 mg and 40 mg BID for 4 weeks in 90 patients with ESRD In this initial study the investigators did not observe a statistically significant reduction in either serum P or salivary P with active therapy as compared to placebo However a clear trend towards a reduction in serum P was seen in the randomized phase of the study with the active gum administered twice a day During the open-label period where the gum was administered thrice-daily the investigators did see a statistically significant reduction in serum P of 03 mgdL Moreover in patients with CKD not on dialysis the investigators observed a reduction in mean serum P of approximately 02 mgdL While not statistically significant this trial was not powered to detect this level of change in serum P and was underpowered to do so Differences in this range 02-04 mgdL have been reported in studies utilizing dietary manipulation plant protein versus animal protein and with the use of Niacin and are felt to be clinically meaningful reductions
The investigators have previously also conducted a cross-sectional observational study evaluating salivary P levels across a wide spectrum of eGFR The data indicate that mean salivary P is uniformly increased 15-25 mgdL relative to serum P 25- 45 mgdL being approximately 5-7X higher as shown below group 1 eGFR 90 group 7 eGFR 15 Importantly salivary P was similar across the entire spectrum of eGFR
The investigators have previously conducted a clinical trial evaluating several different formulations of K2CG with varying amounts of chitosan loading into the gum base variable weights of gum base and 2 different formulations of gum base In these trials the investigators further studied the effects of gum chewing in either the fasted or fed state and the effects of varying amounts of gum chewing time Results from this study have demonstrated that the maximal amount of P loading into the K2CG is seen with the 1g chewing gum containing 20 mg chitosan and that the maximal effect is seen with 30 minutes of gum chewing
Based on data from this study the investigators have chosen this strengthformulation for the primary efficacy endpoint assessment in the current protocol Similar efficacy results with regard to total P loading per chewing gum were seen with the 20 gram 60 mg chitosan chewing gum and there was an indication that subjects had a subjective preference for this formulation As a result this protocol will also assess as a secondary efficacy endpoint the reduction in serum P with this strengthformulation during an open label phase only in those subjects who have responded during the primary efficacy assessment phase This will allow a comparison of efficacy between the 2 gum sizesstrengths among known responders with regard to serum P reduction
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