Value Antiproteinuric Effects From Vitamin D Derivatives in Patient With Chronic Kidney Illness and the Lack of Vitamin D

Clinical Trial, Open, Parallel Groups , Value the Antiproteinuric Effects From Vitamin D Derivatives in Patient With Chronic Kidney Illness and the Lack of Vitamin D

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01442272

Acronym

NEFROVID2010

Enrollment

174

Registered

2011-09-28

Start date

2012-01-31

Completion date

2013-10-31

Last updated

2012-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of Vitamin D, Kidney Failure, Chronic

Brief summary

The purpose of this study is to determine the value the additional antiproteinuric effects of vitamin D derivatives treatment, in patients with Chronic Kidney Illness phase II-IV, with lack of vitamin D and residual proteinuria higher 0,5 grams/day.

Interventions

DRUGHidroferol®

Hidroferol® drinkable ampoule in oral solution, 266 mcg (1 drinkable ampoule) each 15 days during 12 months

DRUGParicalcitol: Zemplar®

Paricalcitol (Zemplar®) oral capsule , 1 mcg (1 capsule)each 24 hours during 12 months

DRUGHabitual medication

Habitual medication

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male/female Patients older 18 years old * Patients have signed written informed consent * Chronic Kidney Illness phase II-IV plus residual proteinuria \>0,5 grams/day (two or more consecutive occasions) and plus beta blockers treatment from AARS during al least 3 months. * Serum levels of calcifediol in the lack of level (15-30 ng/ml).

Exclusion criteria

* Bad control of high blood pressure (higher or same 180/110 mmHg) * Bad control of diabetes (HbA1c higher 9,5 in the last three months period) * Hypercalcemia (\<10,2 mg/dL) o hyperphosphatemia(\>5,5 mg/dL), CaxPO4\>50, hypercalciuria (urin Ca/Cr quotient \> 0,15) * Vitamin D treatment or any analogous * Hepatic failure ( AST o ALT \> 3 times higher than normal limit) * medical history of poor nutrient intestinal absorptions or chronic diarrhea * Active nephrolithiasis * Treatment with medication wich can change vitamin D metabolism (phenobarbital, phenytoin, rifampicin) * Participation in other Clinic Trial in 3 last months * Active Alcoholism * Neoplasia precedent (except cutaneous no melanoma) * Pregnant women or while breastfeeding * Vitamin D hypersensitivity or any its excipient hypersensitivity * Any other condition from Research

Design outcomes

Primary

Measure	Time frame
Protein/creatinine quotient and albumin/creatinine in matinal urine sample: basal and 3 period months after a month of the therapeutic protocol beginning.	1-3 month

Countries

Spain

Contacts

Primary ContactAna Aldea

a.aldea@gmail.com+34922678115

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026