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Anti-proteinuric Effect of Calcitriol in Non-diabetic Kidney Disease Patients

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ClinicalTrials.gov Identifier: NCT01512862
Recruitment Status : Unknown
Verified April 2012 by Yon Su Kim, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : January 19, 2012
Last Update Posted : April 10, 2012
Sponsor:
Information provided by (Responsible Party):
Yon Su Kim, Seoul National University Hospital

Study Description
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Brief Summary:

Proteinuria is not only a marker of chronic kidney disease (CKD) progression, but also a marker of cardiovascular disease and death. In previous studies, active vitamin D deficiency is associated with cardiovascular risk factors such as albuminuria, diabetes mellitus, and lower glomerular filtration rate (GFR). And calcitriol was shown to have a preventive effect in progressive glomerular damage in a renal ablation model. Calcitriol, an active form of vitamin D (1,25-dihydroxyvitamin-D3), is commonly used for the treatment of secondary hyperparathyroidism in patients with advanced chronic kidney diseases.

Therefore, the objective of this study is to evaluate the anti-proteinuric effect of calcitriol in non-diabetic kidney disease patients. They will be treated with calcitriol and placebo for 24 weeks and observed for 24 weeks after treatment. Proteinuria, renal function, serum and urinary inflammatory markers, and adverse event will be monitored.


Condition or disease Intervention/treatment Phase
Proteinuria Drug: Calcitriol Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Additive Renoprotective Effects of Oral Calcitriol in Nondiabetic Chronic Kidney Disease Patients
Study Start Date : January 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Calcitriol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Calcitriol Drug: Calcitriol
Dosage of 0.25 mcg administered orally once daily for 6 weeks and dose escalated to 0.5 mcg orally once daily up to 6 months
Other Name: Calcio® (Hanmi Pharm Co., Korea)
No Intervention: Placebo Drug: Placebo
Dosage of 0.25 mcg administered orally once daily for 6 weeks and dose escalated to 0.5 mcg orally once daily up to 6 months


Outcome Measures
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Primary Outcome Measures :
  1. Changes in proteinuria [ Time Frame: 6, 12 months after administration ]
    Comparison of proteinuria amount checked by random urine protein/creatinine ratio


Secondary Outcome Measures :
  1. Changes in renal function [ Time Frame: 3, 6, 9 and 12 months ]
    Comparison of in serum creatinine level from baseline

  2. Changes in urinary renal damage markers [ Time Frame: 6, 12 months ]
    Comparison of urinary TGF-beta, TNF-alpha, MCP-1 level from baseline


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Nondiabetic kidney disease patients aged 19-70 years
  • MDRD GFR ≥ 30 mL/min/1.73m2
  • Patients with residual urine protein/creatinine ratio > 200 mg/g
  • Adequate blood pressure control as treated systolic blood pressure <=140 or diastolic <=90 mmHg with RAS inhibitor for more than 3 months
  • Normotensive patients untreated with RAS inhibitors
  • Serum intact PTH as 35-500 mg/dL and serum calcium less than 10.2 mg/dL
  • Patients who have not been treated vitamin D within the 3 months prior to signing the informed consent form

Exclusion Criteria:

  • Patients with nephrotic-range proteinuria (24 hour urine protein >3.5 g/24 hr)
  • Patients with rapidly progressive glomerulonephritis
  • Patients requiring renal replacement therapy immediately
  • Hypercalcemia (uncorrected serum calcium level > 10.2 mg/dL) within 3 months
  • Malignant hypertension
  • Heart failure (New York Heart Association [NYHA] functional class II to IV or LVEF less than 40%)
  • Severe chronic obstructive lung disease
  • Decompensated liver disease
  • Known allergy or hypersensitivity to vitamin D
  • Current treatment with steroids and/or immunosuppressive agents
  • No other active primary malignancy requiring treatment or that limits survival to ≤ 2 years
  • History of noncompliance to medical regimen
  • Inability to give an informed consent or to cooperate with researchers (e.g., psychiatric disorder)
Contacts and Locations
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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): NCT01512862


Contacts
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Contact: Nayoung Han, M.S. +82-2-2072-0335 hans1217@snu.ac.kr

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Enrolling by invitation
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Yon Su Kim, M.D., Ph.D.    82-2-2072-2264    yonsukim@snu.ac.kr   
Contact: Dong Ki Kim, M.D., Ph.D.    82-2-2072-2303    dkkim73@gmail.com   
Principal Investigator: Yon Su Kim, M.D., Ph.D.         
Sub-Investigator: Dong Ki Kim, M.D., Ph.D.         
Sub-Investigator: Nayoung Han, M.S.         
SMG-SNU Boramae Medical Center Enrolling by invitation
Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Chair: Jung Mi Oh, Pharm.D. Seoul National Univerisy College of Pharmacy
Principal Investigator: Yon Su Kim, M.D., Ph.D. Seoul National University Hospital
More Information
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Responsible Party: Yon Su Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01512862    
Other Study ID Numbers: SNUH-CCTO
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012
Keywords provided by Yon Su Kim, Seoul National University Hospital:
Calcitriol
Off-label
Additional relevant MeSH terms:
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Kidney Diseases
Proteinuria
Urologic Diseases
Urination Disorders
Urological Manifestations
Calcitriol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents