Trial | NCT01820078  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    paricalcitol ...

  • Study Participants

    127
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.
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.
Study Started
May 31
2012
Primary Completion
Sep 30
2013
Study Completion
Dec 31
2013
Anticipated
Last Update
Nov 28
2013
Estimate

Drug Experimental arm

Oral paricalcitol, 1 ug/day, plus daily treatment. 6 months (all study)

  • Other names: Treatment

Other Comparator Arm

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.

  • Other names: Daily treatment for CKD

Paricalcitol, Daily treatment, CKD Experimental

Experimental Arm

Daily treatment for CKD Other

Comparator Arm

Criteria 

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
No Results Posted