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

NCT ID: NCT03565913

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 269 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-22
• Study Completion Date: 2025-12-31

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

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

Conditions

CKD Stage 5

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

EffCaMgCit

Intervention Type: DRUG

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.

CaAcS

Patients in the CaAcS group will take 45 meq (900 mg) Ca and 45 meq acetate (without Mg or citrate) per day.

Group Type: ACTIVE_COMPARATOR

CaAcS

Intervention Type: OTHER

CaAcS group will take 45 meq (900 mg) Ca and 45 meq acetate (without Mg or citrate), three times daily for 2 years

Interventions

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.

Intervention Type: DRUG

CaAcS

CaAcS group will take 45 meq (900 mg) Ca and 45 meq acetate (without Mg or citrate), three times daily for 2 years

Intervention Type: OTHER

Other Intervention Names

Effervescent calcium magnesium citrate; Calcium acetate suspension/solution

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Henry Quinones

Professor, Internal Medicine - Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henry Quinones, MD

Role: PRINCIPAL_INVESTIGATOR

UTSW

Locations

DaVita Dialysis Centers

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU 122016-001

Identifier Type: -

Identifier Source: org_study_id