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The Effectiveness and Safety of Calcium Carbonate in Chronic Kidney Disease With Normophosphatemia

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ClinicalTrials.gov Identifier: NCT03550534
Recruitment Status : Completed
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborator:
Dr Cipto Mangunkusumo General Hospital
Information provided by (Responsible Party):
Pringgodigdo Nugroho, MD, Indonesia University

Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Drug: Calcium Carbonate Drug: Placebo oral capsule Not Applicable

Detailed Description:

Cardiovascular disease is the most cause of mortality of chronic kidney disease (CKD) patients. As CKD progresses, the prevalence of cardiovascular disease also increased. Beside traditional cardiovascular risk factor that the investigators have known, some non-traditional cardiovascular risk factors were reported to be associated with cardiovascular disease in CKD patients, which one of them was increased level of fibroblast growth factor-23 (FGF23).[1,2]

FGF23 reduces production of 1,25-vitamin D3 and expression of sodium-phosphate cotransport, and also excretes phosphate through urine. In healthy and CKD population, increased phosphate level resulted in increased production of FGF23. Normophosphatemia state in early to moderate stage of CKD was reported due to body compensation by increasing the level of FGF23. On the other hand, increased serum FGF23 level was related to CKD progression, cardiomegaly, vascular calcification, and mortality.[1] There are several ways to prevent hyperphosphatemia, such as low phosphor intake, phosphate binder administration, and adequate dialysis.[3]

Phosphate binder was reported to give positive effects in CKD patients with hyperphosphatemia. Studies which investigated the use of phosphate binder in CKD patients with normophosphatemia to decrease FGF23 were still limited and the result was controversial.[1]

Therefore, this double blind, randomized controlled trial study investigated the effectiveness and safety of calcium carbonate in early to moderate CKD patients with normophosphatemia in lowering FGF23 levels. Study participant were randomized to receive calcium carbonate or placebo for 12 weeks. Before and after intervention, blood and urine sample were taken to examine serum FGF23, serum phosphate, urine phosphate, ionized calcium, serum calcium, urea, creatinine, estimated glomerular filtration rate (eGFR), and albumin. Effectiveness of calcium carbonate administration was indicated by serum FGF23, while safety was indicated by serum calcium.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effectiveness and Safety of Calcium Carbonate in Chronic Kidney Disease With Normophosphatemia: A Double Blind, Randomized Controlled Trial
Actual Study Start Date : November 6, 2015
Actual Primary Completion Date : December 11, 2016
Actual Study Completion Date : December 11, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Calcium Carbonate
Calcium carbonate 3 x 500 mg was given to 23 study participants for 12 weeks
Drug: Calcium Carbonate
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 Comparator: Placebo oral capsule
Placebo oral capsule 3 x 1 was given to 23 study participants for 12 weeks
Drug: Placebo oral capsule
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.




Primary Outcome Measures :
  1. Serum Fibroblast Growth Factor 23 (FGF-23) [ Time Frame: 12 weeks ]
    Serum FGF23 (pg/ml) as cardiovascular risk factor in chronic kidney disease (CKD) was measured and compared between 2 groups before and after intervention


Secondary Outcome Measures :
  1. Serum Calcium Level [ Time Frame: 12 weeks ]
    Serum calcium level (mg/dl) was measured and compared between 2 groups before and after intervention



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

Inclusion Criteria:

  • Stage 3 or 4 chronic kidney disease patient that visit nephrology or endocrinology outpatient clinic of dr. Cipto Mangunkusumo Hospital
  • Normal level of serum phosphate
  • Agreed to join in this study

Exclusion Criteria:

  • Subjects with BMI < 18.5 kg/m2 or > 30 kg/m2
  • Consume drugs which may interfere bone mineral metabolism

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): NCT03550534


Locations
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Indonesia
dr. Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Dr Cipto Mangunkusumo General Hospital
Investigators
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Principal Investigator: Pringgodigdo Nugroho, MD Indonesia University
Principal Investigator: Maruhum Bonar H. Marbun, MD Indonesia University
Principal Investigator: Bella Yunita, MD Indonesia University
Principal Investigator: Cindy Astrella, MD, BMedSci Indonesia University

Publications of Results:
Martin K, Floege J, Ketteler M. Bone and mineral metabolism in chronic kidney disease. In: Johnson R, Feehally J, Floege J, editors. Comprehensive clinical nephrology. Fifth edition. Philadelphia: Saunders; 2015. p. 984-7.
Ketteler M, Leonard M. KDIGO 2016 Clinical practice guideline update on diagnosis, evaluation, prevention, and treatment of CKD-MBD. Off J Int Soc Nephrol. 2016;(August):1-45
Perhimpunan Nefrologi Indonesia. 8th Report of Indonesian Renal Registry. Jakarta; 2015

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Responsible Party: Pringgodigdo Nugroho, MD, Head of Dialysis Unit, Dr Cipto Mangunkusumo General Hospital, Indonesia University
ClinicalTrials.gov Identifier: NCT03550534     History of Changes
Other Study ID Numbers: 198/UN2.F1/ETIK/2015
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Pringgodigdo Nugroho, MD, Indonesia University:
Calcium carbonate
Chronic kidney disease
Normophosphatemia
FGF23
Phosphate binder

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Calcium
Calcium, Dietary
Calcium Carbonate
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents