Paricalcitol on Albuminuria, Inflammation and Fibrosis on Proteinuric Chronic Renal Diseases (PALIFE Study)

Study Overview
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Brief Summary
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The purpose of this study is to estimate the differences between albuminuria values determined as Urine Albumin-to-Creatinine Ratio (UACR)(log transformed) from baseline to last observation caused by paricalcitol between the group of control and group of treatment.

Detailed Description
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Clinical Trial to estimate UACR determined albuminuria differences between treatment and non-treatment groups from basal intake to last study-related observation. Patients should suffer proteinuric Chronical Kidney Disease and recovered levels of seric 25(OH)D. Also, this clinical trial tries to determinate the effect of paricalcitol over several metabolic and inflammatory parameters on patients.

Official Title
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Effect of Paricalcitol on Albuminuria, Inflammation and Fibrosis on Proteinuric Chronic Renal Diseases (PALIFE Study): a Randomized Study

Conditions
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Chronic Kidney Disease, Unspecified

Intervention / Treatment
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* Drug: Experimental arm
* Other: Comparator Arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent signed Patients will be men or women, between 18 and 75 years old. Patients must have been taken an stable dosis of Angiotensine Converter Enzyme Inhibitor, Angiotensine Receptor Antagonism or antialdosterone at last 6 months before screening visit. Patients should not be on dialysis treatment. Women should not be pregnant, or in fertile period (at last 1 year postmenopausal or chirurgic sterilized or using this contraceptive methods: condoms, gel, intrauterine devices, anticonceptives, etc. During at last 3 months after the study beginning. Exclusion Criteria: Patients have taken active vitamin D during 6 months after the screening. Patients with allergy o sensibility to paricalcitol. Patients with acute CKD 12 weeks before the screening. Patients with chronical gastrointestinal disease. Patients with hypo or hyperthyroidism. Patients with secondary hypertension Bad controled hypertension patients Patients with renal lithiasis Patients with drug dependence Patients taking calcitonins, biphosphonates, cinacalcet or others Ca-metabolism drugs. Patients taking immunosuppressor drugs. Patients not adequate to study as medical opinion. HIV patients Seric P > 5.0 mg/dl. Seric Ca> 10,0 mg/dl. Proteinuria > 3.500 mg/g Hypoalbuminemia < 3g/dl

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paricalcitol, Daily treatment, CKD<br>Experimental Arm | Drug: Experimental arm<br>* Oral paricalcitol, 1 ug/day, plus daily treatment. 6 months (all study)<br>* Other names: Treatment;Other: Comparator Arm<br>* Daily treatment is not define by protocol, because daily treatment in CKD is highly variable and includes salt and/or blood pressure regulation, angiotensine system stoppers, controlled diet, etc.<br>* Other names: Daily treatment for CKD;|
| Other: Daily treatment for CKD<br>Comparator Arm | Other: Comparator Arm<br>* Daily treatment is not define by protocol, because daily treatment in CKD is highly variable and includes salt and/or blood pressure regulation, angiotensine system stoppers, controlled diet, etc.<br>* Other names: Daily treatment for CKD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Albuminuria in proteinuric Chronical Kidney Disease patients | Estimate differences between groups based on albuminuric level determined as UACR from basal to last observation visit. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline albuminuria at 6 months | Determinate % of patients with an over 20% of albuminuria descent from baseline | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic, Kidney, Disease, Proteinuria, Albuminuria, Paricalcitol