Ignite Creation Date:
2024-05-06 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03565913
Status:
RECRUITING
Last Update Posted:
2023-10-13
First Post:
2018-05-18
Brief Title:
Potential Therapeutic Role of Effervescent Calcium-Magnesium Citrate in Chronic Kidney Disease Stage V
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Potential Therapeutic Role of Effervescent Calcium-Magnesium Citrate in Chronic Kidney Disease Stage V
Status:
RECRUITING
Status Verified Date:
2023-10
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:
None
Brief Summary:
The Investigators plan to conduct a long-term trial to explore therapeutic implications of effervescent calcium magnesium citrate EffCaMgCit in CKD Stage V end stage renal disease on hemodialysis The Investigators will test the hypothesis that EffCaMgCit would retard the formation of calciprotein particles CPP in CKD Stage V thereby reducing the degree of coronary artery and peripheral artery calcification and cardiac hypertrophy-fibrosis
Aim 1 To compare cardiovascular risk of EffCaMgCit versus CaAcS in CKD Stage V Aim 2 To show that EffCaMgCit reduces putative serum FGF23 and increases beneficial alkali load Aim 3 To compare parameters of bone turnover and bone mineral density BMD between EffCaMgCit and CaAcS groups
Aim 1 To compare cardiovascular risk of EffCaMgCit versus CaAcS in CKD Stage V Aim 2 To show that EffCaMgCit reduces putative serum FGF23 and increases beneficial alkali load Aim 3 To compare parameters of bone turnover and bone mineral density BMD between EffCaMgCit and CaAcS groups
Detailed Description:
150 adult subjects 21 years of age any cause of CKD of either gender of any ethnicity with CKD Stage V on hemodialysis will be recruited from Davita-UTSW dialysis centers and randomized into two equal groups in a parallel design stratified according to gender and age or 50 years After baseline evaluation one group EffCaMgCit Group will take EffCaMgCit and the other group CaAcS Group will take calcium acetate suspensionsolution for two years Both drugs will be taken 1 sachet each just before or along with breakfast and dinner for the first three months If tolerated the dose will be increased to 1 sachet tid just before or along with breakfast lunch and dinner
After screening and a baseline evaluation research personnel will visit patients at the dialysis center every three months for two years Patients will be evaluated with a medical history side effect questionnaires blood pressure measurements blood tests echocardiograms coronary artery calcification analyses muscle magnesium analyses and bone mineral density analyses
It is expected that markers of cardiovascular risk would be improved in patients taking CaMgCit and would remain stable in those taking CaAcS
Endpoint Expectations
During treatment with EffCaMgCit T50 would increase indicative of reduced propensity for CPP formation
Serum Mg inhibitor of CPP formation would be increased by EffCaMgCit
An increase in intracellular muscle Mg would show that EffCaMgCit provides a Mg load and also indicates repletion of Mg stores that might be cardioprotective independently of effects on CPP formation
The Investigators anticipate that serum FGF23 would be lower and serum Klotho would be higher on EffCaMgCit
After screening and a baseline evaluation research personnel will visit patients at the dialysis center every three months for two years Patients will be evaluated with a medical history side effect questionnaires blood pressure measurements blood tests echocardiograms coronary artery calcification analyses muscle magnesium analyses and bone mineral density analyses
It is expected that markers of cardiovascular risk would be improved in patients taking CaMgCit and would remain stable in those taking CaAcS
Endpoint Expectations
During treatment with EffCaMgCit T50 would increase indicative of reduced propensity for CPP formation
Serum Mg inhibitor of CPP formation would be increased by EffCaMgCit
An increase in intracellular muscle Mg would show that EffCaMgCit provides a Mg load and also indicates repletion of Mg stores that might be cardioprotective independently of effects on CPP formation
The Investigators anticipate that serum FGF23 would be lower and serum Klotho would be higher on EffCaMgCit
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