Study Stopped
Recruitment not reached
Paricalcitol on Albuminuria, Inflammation and Fibrosis on Proteinuric Chronic Renal Diseases (PALIFE Study)
PALIFE
Effect of Paricalcitol on Albuminuria, Inflammation and Fibrosis on Proteinuric Chronic Renal Diseases (PALIFE Study): a Randomized Study
1 other identifier
interventional
127
1 country
25
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 paricalcitol between the group of control and group of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2012
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 30, 2012
CompletedFirst Posted
Study publicly available on registry
March 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedNovember 28, 2013
November 1, 2013
1.3 years
July 30, 2012
November 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Albuminuria in proteinuric Chronical Kidney Disease patients
Estimate differences between groups based on albuminuric level determined as UACR from basal to last observation visit.
1 year
Secondary Outcomes (1)
Change from baseline albuminuria at 6 months
6 months
Study Arms (2)
Paricalcitol, Daily treatment, CKD
EXPERIMENTALExperimental Arm
Daily treatment for CKD
OTHERComparator Arm
Interventions
Oral paricalcitol, 1 ug/day, plus daily treatment. 6 months (all study)
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Hospital Universitario General de Alicante
Alicante, Alicante, 03010, Spain
Hospital Son Espases
Mallorca, Balearic Islands, 07010, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08035, Spain
Fundació Puigvert
Barcelona, Barcelona, 08025, Spain
Hospital Valle de Hebrón
Barcelona, Barcelona, 08035, Spain
Hospital de Galdakao
Bilbao, Basque Country, 48960, Spain
Hospital Virgen de la Candelaria
Santa Cruz de Tenerife, Canary Islands, 38010, Spain
Hospital Reina Sofía
Córdoba, Córdoba, 14004, Spain
Hospital Virgen de las Nieves
Granada, Granada, 18014, Spain
Hospital Comarcal Da Costa
Burela de Cabo, Lugo, 27880, Spain
Hosp. U. Fundación de Alcorcón
Alcorcón, Madrid, 28922, Spain
Hospital Gregorio Marañon
Madrid, Madrid, 28007, Spain
Hospital Ramon y Cajal
Madrid, Madrid, 28034, Spain
Clínico San Carlos
Madrid, Madrid, 28040, Spain
Fundación Jiménez Díaz
Madrid, Madrid, 28040, Spain
Hospital 12 de Octubre
Madrid, Madrid, 28046, Spain
Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Hospital Infanta Sofía
San Sebastián de los Reyes, Madrid, 28702, Spain
Hospital Carlos Haya
Málaga, Málaga, 29010, Spain
Hospital Universitario Virgen de la Macarena
Seville, Sevilla, 41009, Spain
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013, Spain
Hospital General Universitario de Valencia
Valencia, Valencia, 46014, Spain
Hospital Dr Peset
Valencia, Valencia, 46017, Spain
Hospital Clinico Lozano Blesa
Zaragoza, Zaragoza, 50009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesús Egido de los Ríos, MD
Fundación Renal Iñigo Alvarez De Toledo
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2012
First Posted
March 28, 2013
Study Start
May 1, 2012
Primary Completion
September 1, 2013
Study Completion
December 1, 2013
Last Updated
November 28, 2013
Record last verified: 2013-11