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

NCT03565913 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: STU 122016-001
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

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

Conditions

CKD Stage 5

Outcome Measures

Primary Outcomes (1)

• Serum T50 for CPP

  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.

  24 months

Secondary Outcomes (3)

• Intracellular muscle magnesium

  24 months

• Control of hyperphosphatemia and serum FGF23

  24 months

• Parathyroid function and bone turnover

  24 months

Study Arms (2)

EffCaMgCit

EXPERIMENTAL

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

CaAcS

ACTIVE COMPARATOR

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

Other: CaAcS

Interventions

EffCaMgCit 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.

Also known as: Effervescent calcium magnesium citrate

EffCaMgCit

CaAcS OTHER

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

Also known as: Calcium acetate suspension/solution

CaAcS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

DaVita Dialysis Centers

Dallas, Texas, 75224, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

effervescent calcium magnesium citrate; Solutions

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Henry Quinones, MD

  UTSW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Internal Medicine - Nephrology

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 21, 2018
• Study Start: January 22, 2017
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

US (1)