Calcitriol in the Treatment of Immunoglobulin A (IgA) Nephropathy

NCT00319761 | Completed Phase 4

• 1 other identifier: CREC-2006.120
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in the world. A wealth of literature suggests that vitamin D and its analogs have profound effects on immune system function and glomerular mesangial cell proliferation. Calcitriol, an active form of vitamin D, is commonly used for the treatment of secondary hyperparathyroidism in patients with advanced chronic kidney diseases. Therefore, the investigators plan to conduct a open-label single-arm study to evaluate the safety and efficacy of calcitriol in the treatment of IgA nephropathy. Ten patients with biopsy-proven IgA nephropathy and persistent proteinuria despite conventional therapy will be recruited. They will be treated with calcitriol for 12 weeks. Proteinuria, renal function, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and anti-inflammatory effects of calcitriol in the treatment of IgA nephropathy, which is a major cause of dialysis-dependent renal failure.

Conditions

IGA Nephropathy

Keywords

glomerulonephritis; proteinuria; chronic kidney diseases

Outcome Measures

Primary Outcomes (1)

• Primary end point of the study is the change in the degree of proteinuria.

Secondary Outcomes (1)

• Secondary end points include the change in renal function and other serum inflammatory markers.

Interventions

Calcitriol DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18-65 years
• biopsy-confirmed IgA nephropathy
• proteinuria \> 1 g/day (or proteinuria \> 1 g/g-Cr) in 2 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker treatment (ramipril 5 mg daily, lisinopril 10 mg daily, or valsartan 80 mg daily) for at least 3 months
• estimated glomerular filtration rate 15 to 60 ml/min/1.73m2
• corrected serum calcium level M 2.45 mmol/l
• willingness to give written consent and comply with the study protocol

You may not qualify if:

• Pregnancy, lactating or childbearing potential without effective method of birth control
• Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication
• History of malignancy, including leukemia and lymphoma within the past 2 years
• Systemic infection requiring therapy at study entry
• Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
• History of drug or alcohol abuse within past 2 years
• Participation in any previous trial on vitamin D analogue
• Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 3 months
• Patients receiving treatment of corticosteroid
• On other investigational drugs within last 30 days
• History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study
• History of non-compliance
• Known history of sensitivity or allergy to vitamin D analogs

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Medicine & Therapeutics, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

• Szeto CC, Chow KM, Kwan BC, Chung KY, Leung CB, Li PK. Oral calcitriol for the treatment of persistent proteinuria in immunoglobulin A nephropathy: an uncontrolled trial. Am J Kidney Dis. 2008 May;51(5):724-31. doi: 10.1053/j.ajkd.2007.12.038. Epub 2008 Apr 3.

  PMID: 18436082 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA; Glomerulonephritis; Proteinuria; Renal Insufficiency, Chronic

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Cheuk-Chun Szeto, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 27, 2006
• First Posted: April 27, 2006
• Study Start: May 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: January 30, 2009

Record last verified: 2009-01

Locations

HK (1)