Overview

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

Status:
Terminated
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fundación Renal Iñigo Alvarez De Toledo
Collaborator:
Effice Servicios Para la Investigacion S.L.
Treatments:
Ergocalciferols
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