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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yon Su Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01512862
First received: January 13, 2012
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Proteinuria
Drug: Calcitriol
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Additive Renoprotective Effects of Oral Calcitriol in Nondiabetic Chronic Kidney Disease Patients

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Changes in proteinuria [ Time Frame: 6, 12 months after administration ] [ Designated as safety issue: No ]
    Comparison of proteinuria amount checked by random urine protein/creatinine ratio


Secondary Outcome Measures:
  • Changes in renal function [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
    Comparison of in serum creatinine level from baseline

  • Changes in urinary renal damage markers [ Time Frame: 6, 12 months ] [ Designated as safety issue: No ]
    Comparison of urinary TGF-beta, TNF-alpha, MCP-1 level from baseline


Estimated Enrollment: 240
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512862

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

Locations
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
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

No publications provided

Responsible Party: Yon Su Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01512862     History of Changes
Other Study ID Numbers: SNUH-CCTO
Study First Received: January 13, 2012
Last Updated: April 9, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Calcitriol
Off-label

Additional relevant MeSH terms:
Proteinuria
Kidney Diseases
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Calcitriol
Bone Density Conservation Agents
Calcium Channel Agonists
Cardiovascular Agents
Growth Substances
Membrane Transport Modulators
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents
Vitamins

ClinicalTrials.gov processed this record on October 21, 2014