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

April 9, 2012 updated by: Yon Su Kim, Seoul National University Hospital

Additive Renoprotective Effects of Oral Calcitriol in Nondiabetic Chronic Kidney Disease Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yon Su Kim, M.D., Ph.D.
        • Sub-Investigator:
          • Dong Ki Kim, M.D., Ph.D.
        • Sub-Investigator:
          • Nayoung Han, M.S.
      • Seoul, Korea, Republic of, 156-707
        • Enrolling by invitation
        • SMG-SNU Boramae Medical Center
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
        • Enrolling by invitation
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 Names:
  • Calcio® (Hanmi Pharm Co., Korea)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in proteinuria
Time Frame: 6, 12 months after administration
Comparison of proteinuria amount checked by random urine protein/creatinine ratio
6, 12 months after administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in renal function
Time Frame: 3, 6, 9 and 12 months
Comparison of in serum creatinine level from baseline
3, 6, 9 and 12 months
Changes in urinary renal damage markers
Time Frame: 6, 12 months
Comparison of urinary TGF-beta, TNF-alpha, MCP-1 level from baseline
6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

January 13, 2012

First Submitted That Met QC Criteria

January 18, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Estimate)

April 10, 2012

Last Update Submitted That Met QC Criteria

April 9, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-CCTO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Proteinuria

Clinical Trials on Calcitriol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe