Overview
Paricalcitol on Albuminuria, Inflammation and Fibrosis on Proteinuric Chronic Renal Diseases (PALIFE Study)
Status:
Terminated
Terminated
Trial end date:
2013-12-01
2013-12-01
Target enrollment:
0
0
Participant gender:
All
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 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Fundación Renal Iñigo Alvarez De ToledoCollaborator:
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