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Potential Therapeutic Role of Effervescent Calcium-Magnesium Citrate in Chronic Kidney Disease Stage V

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ClinicalTrials.gov Identifier: NCT03565913
Recruitment Status : Active, not recruiting
First Posted : June 21, 2018
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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


Condition or disease Intervention/treatment Phase
CKD Stage 5 Drug: EffCaMgCit Other: CaAcS Phase 2 Phase 3

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 suspension/solution 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized into two groups in a parallel design. One group will take EffCaMgCit 15 meq (300 mg) Ca, 10 meq Mg (122 mg) and 45 meq total citrate thrice daily, while the other group will take calcium acetate suspension/solution (CaAcS) 15 meq Ca thrice daily for two years.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: To provide adequate blinding, each medication sachet will be labelled with the study name, IRB number, principal investigator's name, expiration date and identification number of the study subject. Labels will be applied to the appropriate medication sachets once the subject has been randomized and assigned to a treatment group. Labelling of the sachets will be done by non-patient care personnel.
Primary Purpose: Treatment
Official Title: Potential Therapeutic Role of Effervescent Calcium-Magnesium Citrate in Chronic Kidney Disease Stage V
Actual Study Start Date : January 22, 2017
Estimated Primary Completion Date : January 22, 2021
Estimated Study Completion Date : January 22, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EffCaMgCit
Patients in the EffCaMgCit group will receive 45 meq (900 mg) Ca, 30 meq (365 mg) Mg, and 135 meq total citrate per day from 3 months to 2 years.
Drug: EffCaMgCit
Patients in the EffCaMgCit group will receive 45 meq (900 mg) Ca, 30 meq (365 mg) Mg, and 135 meq total citrate per day from 3 months to 2 years.
Other Name: Effervescent calcium magnesium citrate

Active Comparator: CaAcS
Patients in the CaAcS group will take 45 meq (900 mg) Ca and 45 meq acetate (without Mg or citrate) per day.
Other: CaAcS
CaAcS group will take 45 meq (900 mg) Ca and 45 meq acetate (without Mg or citrate), three times daily for 2 years
Other Name: Calcium acetate suspension/solution




Primary Outcome Measures :
  1. Serum T50 for CPP [ Time Frame: 24 months ]
    The maturation time (T50) of calciprotein particles in serum will be measured. T50 CPP (measured by Calcisco using Pasch's method) assays the kinetics of transformation from primary to secondary CPP in vitro. Fresh serum samples will be kept at -80 degrees until shipment to Calcisco AG (Berne, Switzerland) for T50 analysis, which will determine T50 of CPP through research collaboration with CMMCR.


Secondary Outcome Measures :
  1. Intracellular muscle magnesium [ Time Frame: 24 months ]
    Intracellular Mg will be measured in calf muscle, by using 31P magnetic resonance spectroscopy, based on the formula: [Mg] - kd(10.796-D)/(D-8.251), in which kd is the dissociation constant for MgATP complex (=50 µM) and D is the chemical shift difference between alpha- and beta-ATP 31P signals observed in 31P MR spectrum.

  2. Control of hyperphosphatemia and serum FGF23 [ Time Frame: 24 months ]
    The control of hyperphosphatemia will be evaluated from changes in serum P concentration, serum FGF23 and Klotho.

  3. Parathyroid function and bone turnover [ Time Frame: 24 months ]
    Parathyroid function will be evaluated from serum PTH, vitamin D status from serum calcitriol, bone resorption from serum CTX, and bone formation from serum BSAP. Change in bone mass will be evaluated by BMD (proximal femur, L2-L4 spine and distal third of radius).



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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. Patients with Type II diabetes and hypertension will be allowed. Treatment with drugs for management of osteoporosis (bisphosphonate, teriparatide, or denosumab) or for chronic kidney disease, customary drugs for hypertension or diabetes, and exogenous estrogen or selective estrogen receptor modulators will be allowed.

Exclusion Criteria:

  • Patients with serum Mg > 3.65 mg/dL (3 meq/L) will be excluded (de Francisco, 2010). Also excluded from the study will be those with bowel disease, hypercalcemia, hypophosphatemia (serum P < 2.5 mg/dL) and treatment with adrenocorticosteroids or aluminum-containing antacids or drugs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565913


Locations
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United States, Texas
DaVita Dialysis Centers
Dallas, Texas, United States, 75224
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Henry Quinones, MD UTSW

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03565913    
Other Study ID Numbers: STU 122016-001
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Calcium, Dietary
Magnesium citrate
Calcium
Calcium acetate
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Cathartics
Gastrointestinal Agents