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

History of Changes

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:

MedlinePlus related topics: Kidney Diseases

Drug Information available for: Calcitriol

U.S. FDA Resources

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:


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 March 03, 2015

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