Status:
TERMINATED
Paricalcitol on Albuminuria, Inflammation and Fibrosis on Proteinuric Chronic Renal Diseases (PALIFE Study)
Lead Sponsor:
Fundación Renal Iñigo Alvarez De Toledo
Collaborating Sponsors:
Effice Servicios Para la Investigacion S.L.
Conditions:
Chronic Kidney Disease, Unspecified
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
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 Ch...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT01820078
Start Date
May 1 2012
End Date
December 1 2013
Last Update
November 28 2013
Active Locations (25)
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1
Hospital Universitario General de Alicante
Alicante, Alicante, Spain, 03010
2
Hospital Son Espases
Mallorca, Balearic Islands, Spain, 07010
3
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08035
4
Fundació Puigvert
Barcelona, Barcelona, Spain, 08025