CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
Calcium Carbonate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03550534
NCT03550534N/ACompleted

The Effectiveness and Safety of Calcium Carbonate in Chronic Kidney Disease With Normophosphatemia: A Double Blind, Randomized Controlled Trial

Indonesia University·interventional·Posted Jun 8, 2018·Updated Jun 8, 2018

In Brief

A clinical study evaluating Calcium Carbonate and Placebo oral capsule for Chronic Kidney Diseases. Completed, enrolled 46 participants across 1 site.

Detailed Summary

Background: Patient with stage 3 or 4 chronic kidney disease (CKD) usually has normal level of serum phosphate, due to increased serum fibroblast growth factor-23 (FGF23) level that resulted in increased phosphate urine excretion. On the other hand, serum FGF23 elevation was related to CKD progression, vascular calcification, cardiomegaly, and mortality. This double blind, randomized controlled trial study was conducted to evaluate effectiveness and safety of calcium carbonate administration in stage 3 or 4 CKD patients with normophosphatemia. Hypothesis: Calcium carbonate administration is effective and safe in chronic kidney disease (CKD) with normophosphatemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndonesia

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 8, 2018
Enrollment StartNov 6, 2015
Primary CompletionDec 11, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.1 years ago

Interventions

Calcium Carbonatedrug

Calcium carbonate was obtained from Pharmacy Department, Faculty of Medicine, University of Indonesia. Subjects were randomized to receive calcium carbonate or placebo for 12 weeks.

Placebo oral capsuledrug

Placebo oral capsule was also obtained from Pharmacy Department, Faculty of Medicine, University of Indonesia. Subjects were randomized to receive calcium carbonate or placebo for 12 weeks.