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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

Tracking Information
First Submitted Date  ICMJE January 13, 2012
First Posted Date  ICMJE January 19, 2012
Last Update Posted Date April 10, 2012
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2012)
Changes in proteinuria [ Time Frame: 6, 12 months after administration ]
Comparison of proteinuria amount checked by random urine protein/creatinine ratio
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2012)
  • Changes in renal function [ Time Frame: 3, 6, 9 and 12 months ]
    Comparison of in serum creatinine level from baseline
  • Changes in urinary renal damage markers [ Time Frame: 6, 12 months ]
    Comparison of urinary TGF-beta, TNF-alpha, MCP-1 level from baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anti-proteinuric Effect of Calcitriol in Non-diabetic Kidney Disease Patients
Official Title  ICMJE Additive Renoprotective Effects of Oral Calcitriol in Nondiabetic Chronic Kidney Disease Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Proteinuria
Intervention  ICMJE
  • 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)
  • 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
Study Arms  ICMJE
  • Experimental: Calcitriol
    Intervention: Drug: Calcitriol
  • No Intervention: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 18, 2012)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01512862
Other Study ID Numbers  ICMJE SNUH-CCTO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yon Su Kim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Seoul National University Hospital
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP