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

Primary Purpose

Proteinuria

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Calcitriol
Placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proteinuria focused on measuring Calcitriol, Off-label

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Seoul National University Bundang Hospital
  • Seoul National University HospitalRecruiting
  • SMG-SNU Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Calcitriol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Changes in proteinuria
Comparison of proteinuria amount checked by random urine protein/creatinine ratio

Secondary Outcome Measures

Changes in renal function
Comparison of in serum creatinine level from baseline
Changes in urinary renal damage markers
Comparison of urinary TGF-beta, TNF-alpha, MCP-1 level from baseline

Full Information

First Posted
January 13, 2012
Last Updated
April 9, 2012
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01512862
Brief Title
Anti-proteinuric Effect of Calcitriol in Non-diabetic Kidney Disease Patients
Official Title
Additive Renoprotective Effects of Oral Calcitriol in Nondiabetic Chronic Kidney Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proteinuria
Keywords
Calcitriol, Off-label

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Calcitriol
Arm Type
Experimental
Arm Title
Placebo
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Other Intervention Name(s)
Calcio® (Hanmi Pharm Co., Korea)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in proteinuria
Description
Comparison of proteinuria amount checked by random urine protein/creatinine ratio
Time Frame
6, 12 months after administration
Secondary Outcome Measure Information:
Title
Changes in renal function
Description
Comparison of in serum creatinine level from baseline
Time Frame
3, 6, 9 and 12 months
Title
Changes in urinary renal damage markers
Description
Comparison of urinary TGF-beta, TNF-alpha, MCP-1 level from baseline
Time Frame
6, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nayoung Han, M.S.
Phone
+82-2-2072-0335
Email
hans1217@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Mi Oh, Pharm.D.
Organizational Affiliation
Seoul National Univerisy College of Pharmacy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yon Su Kim, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Enrolling by invitation
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yon Su Kim, M.D., Ph.D.
Phone
82-2-2072-2264
Email
yonsukim@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Dong Ki Kim, M.D., Ph.D.
Phone
82-2-2072-2303
Email
dkkim73@gmail.com
First Name & Middle Initial & Last Name & Degree
Yon Su Kim, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Dong Ki Kim, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Nayoung Han, M.S.
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Individual Site Status
Enrolling by invitation

12. IPD Sharing Statement

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

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