- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00319761
Calcitriol in the Treatment of Immunoglobulin A (IgA) Nephropathy
The Safety and Short-Term Efficacy of Calcitriol in the Treatment of Immunoglobulin A Nephropathy
Study Overview
Detailed Description
This is a open-label and single arm study. We plan to recruit 10 patients with biopsy-proven IgA nephropathy will be recruited.
Treatment regimen and dosage adjustment
At week 0, all patients will receive calcitriol (oral capsule) at a fixed dose of 0.5 mcg twice weekly. If there is no adverse effect and corrected serum calcium remains < 2.55 mmol/l, the dose of calcitriol will be maintained for 12 weeks.
If corrected serum calcium is 2.55 to 2.62 mmol/l, the dose of calcitriol will be reduced to 0.25 mcg twice weekly. Serum calcium will be rechecked after 2 weeks (or more frequently if indicated). If corrected serum calcium remains < 2.55 mmol/l, the dose of calcitriol will be maintained for the rest of the study period. If corrected serum calcium remains > 2.62 mmol/l for two consecutive measurements despite reducing the dose of calcitriol, the study medication will be stopped and the subject will be discontinued from the study.
If corrected serum calcium is > 2.75 mmol/l at any time, hold calcitriol for one week and repeat laboratory test for calcium. If the subject's next serum calcium is < 2.62 mmol/l, calcitriol may be restarted at 0.25 mcg twice weekly. If the next serum calcium level is > 2.62 mmol/l, the subject will be discontinued from the study.
Concomitant therapy
Prior to enrollment, all of the patients will be stable while receiving ACE inhibitor or angiotensin receptor blocker. Anti-hypertensive therapy will be titrated throughout the study period to maintain the blood pressure below 130 / 80 mmHg.
Visit schedule
Follow up visits will take place according to the following schedule:
- week -4 (screening)
- weeks 0 (start calcitriol), 2, 4, 6, 8, 12 (stop calcitriol) and 16
During every visit, the following parameters will be measured: body weight, blood pressure, pulse, adverse effects of treatment, complete blood picture, differential white cell count, renal function test, liver enzymes, serum calcium, phosphate, and early morning urine collection for protein-to-creatinine ratio. Renal function is determined by the estimated glomerular filtration rate (GFR) according to a standardized formula [20]. Serum fasting glucose and lipid profile will be measured at 0 and 12 weeks.
In order to examine the anti-proliferative and anti-inflammatory action of calcitriol, serum level of C-reactive protein (CRP), interleukin-6 (IL-6) and transforming growth factor-beta (TGF), and urinary levels of TGF, hepatocyte growth factor (HGF), monocyte chemoattractant protein-1 (MCP-1) and thrombospondin-1 (TSP-1) will be measured at 0, 4, 12 and 16 weeks by ELISA. The above panel of cytokine is chosen because of their documented relevance in IgA nephropathy and progressive renal failure [16,19,21-27].
End points
Primary end point of the study is the change in the degree of proteinuria. Secondary end points include the change in renal function and other serum inflammatory markers.
Adverse events
Information about every adverse event will be collected and recorded. An adverse event is any undesirable symptom or medical condition occurring after starting the study medication, whether considered drug-related or not.
Patient withdrawal
The patient will be withdrawn from the study for:
- death
- doubling of baseline serum creatinine level
- pregnancy
- hypercalcemia (serum calcium > 2.62 mmol/L for two consecutive measurements)
- any other intolerable adverse events
- significant non-compliance with the protocol
- the desire of the patient to withdraw from the study All female patients will be advised on taking effective contraceptive measures during the study period.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- Department of Medicine & Therapeutics, Prince of Wales Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Primary end point of the study is the change in the degree of proteinuria.
|
Secondary Outcome Measures
Outcome Measure |
---|
Secondary end points include the change in renal function and other serum inflammatory markers.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Urologic Diseases
- Nephritis
- Glomerulonephritis
- Kidney Diseases
- Glomerulonephritis, IGA
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Micronutrients
- Membrane Transport Modulators
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vasoconstrictor Agents
- Calcium Channel Agonists
- Calcitriol
Other Study ID Numbers
- CREC-2006.120
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 IGA Nephropathy
-
Josep M CruzadoWyeth is now a wholly owned subsidiary of PfizerCompletedGlomerulonephritis, IGA | IGA Nephropathy | Nephropathy, IGASpain
-
Visterra, Inc.CompletedImmunoglobulin A Nephropathy | IgA Nephropathy | IgAN - IgA NephropathyUnited States
-
Rigel PharmaceuticalsCompletedIGA NephropathyUnited States, United Kingdom, Hong Kong, Taiwan, Austria, Germany
-
Uppsala University HospitalHaukeland University Hospital; University Hospital, Linkoeping; Smerud Medical...UnknownIGA NephropathyNorway, Sweden
-
Calliditas Therapeutics ABArchimedes Development LtdCompletedIGA NephropathySweden
-
Sun Yat-sen UniversityUnknownIGA NephropathyChina
-
Guangdong Provincial People's HospitalCompletedGlomerulonephritis | IGA NephropathyChina
-
Nanjing University School of MedicineCompleted
-
Rigel PharmaceuticalsWithdrawn
-
Zhi-Hong Liu, M.D.Completed
Clinical Trials on Calcitriol
-
Rockefeller UniversityCompletedAdenocarcinoma | Colorectal Polyps | Colorectal AdenomaUnited States
-
ShireCompleted
-
Centro de Excelencia en Enfermedades de Cabeza...IPS universitariaNot yet recruitingGoiter | Hyperthyroidism | Thyroid Cancer | ThyroiditisColombia
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyTerminatedProstate Cancer | Precancerous/Nonmalignant ConditionUnited States
-
Galderma R&DCompletedPlaque PsoriasisUnited States
-
Atlanta VA Medical CenterEmory UniversityWithdrawn
-
OHSU Knight Cancer InstituteCompletedProstate CancerUnited States
-
Atlanta VA Medical CenterEmory UniversityCompletedRheumatoid Arthritis | Crohn's DiseaseUnited States
-
National Center for Research Resources (NCRR)Boston UniversityCompleted
-
CHU de Quebec-Universite LavalRecruitingQuality of Life | Hypoparathyroidism PostproceduralCanada