Chronic Kidney Disease, Unspecified
Conditions
Keywords
Chronic, Kidney, Disease, Proteinuria, Albuminuria, Paricalcitol
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.
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 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.
Interventions
DRUGExperimental arm
Oral paricalcitol, 1 ug/day, plus daily treatment. 6 months (all study)
OTHERComparator Arm
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.
Sponsors
Effice Servicios Para la Investigacion S.L.
Fundación Renal Iñigo Alvarez De Toledo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Albuminuria in proteinuric Chronical Kidney Disease patients | 1 year | Estimate differences between groups based on albuminuric level determined as UACR from basal to last observation visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline albuminuria at 6 months | 6 months | Determinate % of patients with an over 20% of albuminuria descent from baseline |
Countries
Spain
Outcome results
None listed