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

Proteinuria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01512862
• Other study ID #: SNUH-CCTO
• Status: Recruiting
• Phase: Phase 4
• First received: January 13, 2012
• Last updated: April 9, 2012
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2012
• Source: Seoul National University Hospital
• Contact: Nayoung Han, M.S.
• Phone: +82-2-2072-0335
• Email: hans1217[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Proteinuria

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in proteinuria	Comparison of proteinuria amount checked by random urine protein/creatinine ratio	6, 12 months after administration	No
Secondary	Changes in renal function	Comparison of in serum creatinine level from baseline	3, 6, 9 and 12 months	No
Secondary	Changes in urinary renal damage markers	Comparison of urinary TGF-beta, TNF-alpha, MCP-1 level from baseline	6, 12 months	No