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

Fundación Renal Iñigo Alvarez De Toledo

Status and phase: Terminated; Phase 4

Conditions: Chronic Kidney Disease, Unspecified

Treatments: Other: Comparator Arm; Drug: Experimental arm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01820078

PALIFE-2011-01

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 127 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

127 participants in 2 patient groups

Paricalcitol, Daily treatment, CKD

Experimental group

Description:

Experimental Arm

Treatment:

Drug: Experimental arm

Other: Comparator Arm

Daily treatment for CKD

Other group

Description:

Comparator Arm

Treatment:

Other: Comparator Arm