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NCT03565913 · ClinicalTrials.gov registry record · Phase 2
Potential Therapeutic Role of Effervescent Calcium-Magnesium Citrate in Chronic Kidney Disease Stage V
A Phase 2 study of CKD Stage 5, sponsored by University of Texas Southwestern Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 269
- Enrollment target
- 1
- Study location
NCT03565913: Active Phase 2 study of CKD Stage 5, sponsored by University of Texas Southwestern Medical Center.
NCT03565913 is a Phase 2 study of CKD Stage 5 that is active but no longer recruiting, run by University of Texas Southwestern Medical Center. The registered enrollment target is 269 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (102% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03565913, a Phase 2 study of CKD Stage 5, is active but no longer recruiting, sponsored by University of Texas Southwestern Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 269 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG EffCaMgCit
- OTHER CaAcS
Study Locations (1)
Texas
- DaVita Dialysis Centers - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 269 participants |
| Start Date | 2017-01-22 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What the registry record for NCT03565913 still lists
NCT03565913 is an interventional study that assigns participants to a tested intervention. The registered 269 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (102% higher).
The record links to 1 condition, with CKD Stage 5 appearing as the primary indexed condition, and to 2 interventions - of which EffCaMgCit is the first listed.
NCT03565913 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03565913 about?
NCT03565913 is a clinical study titled "Potential Therapeutic Role of Effervescent Calcium-Magnesium Citrate in Chronic Kidney Disease Stage V". 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 calciprote...
What is the current status of trial NCT03565913?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 269 participants. The study started on 2017-01-22. Estimated completion is 2025-12-31.
What conditions does trial NCT03565913 study?
This clinical trial studies the following conditions: CKD Stage 5.
What interventions are being tested in trial NCT03565913?
The interventions under investigation include: EffCaMgCit (DRUG), CaAcS (OTHER).
Who is sponsoring clinical trial NCT03565913?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03565913 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03565913's enrollment target sits among peer trials
269 208th of 2000 higher than 1,793 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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