Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will help to show the efficacy of vitamin D and address the optimal strategy to minimize renal injury in IgAN patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01512862

Proteinuria

UNKNOWN PHASE4

Calcitriol in the Treatment of Immunoglobulin A Nephropathy

NCT00862693

Glomerulonephritis Autoimmune Diseases

UNKNOWN PHASE4

Clinical Trial Technology Development for the Validation of Surrogate Prognostic Markers in Patients With Diabetic Nephropathy

NCT01673204

Diabetic Nephropathy

UNKNOWN PHASE4

Calcitriol in the Treatment of Immunoglobulin A (IgA) Nephropathy

NCT00319761

IGA Nephropathy

COMPLETED PHASE4

Impact of Vitamin D Therapies on Chronic Kidney Disease

NCT01222234

Chronic Kidney Disease (CKD) End-stage Renal Disease (ESRD)

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

IgA Nephropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

oral calcitriol

Calcio®

Group Type EXPERIMENTAL

Calcitriol

Intervention Type DRUG

Calcitriol(1,25-dihydroxycholecalciferol, vitamin D3 analog)0.25 μg per day

placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Calcitriol

Calcitriol(1,25-dihydroxycholecalciferol, vitamin D3 analog)0.25 μg per day

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Biopsy-proven Ig AN patients aged 20-70 years
* Patients with residual proteinuria \> 500 mg/g creatinine despite renin-angiotensin system blockade and adequate blood pressure control for more than 3 months
* Patients who give informed consent, and 4) estimated GFR \>= 30 ml/min/1.73 m2.

Exclusion Criteria

* patients \< 20 years or \> 70 years
* hypersensitivity to vitamin D analogs
* patients who need urgent dialysis
* hypercalcemia within 3 months (uncorrected serum calcium level \> 10.2 mg/dL)
* clinical features of rapidly progressive glomerulonephritis
* life expectancy less than 24 months
* uncontrolled hypertension
* decompensated liver or lung disease
* symptomatic heart failure (NYHA class II-IV or LVEF \< 40%)
* estimated GFR \< 30 ml/min/1.73 m2.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No