Value Antiproteinuric Effects From Vitamin D Derivatives in Patient With Chronic Kidney Illness and the Lack of Vitamin D (NEFROVID2010)

Hospital Universitario de Canarias

Status and phase: Unknown; Phase 4

Conditions: Disorder of Vitamin D; Kidney Failure, Chronic

Treatments: Drug: Habitual medication; Drug: Paricalcitol: Zemplar®; Drug: Hidroferol®

Study type: Interventional

Funder types: Other

Identifiers

NCT01442272

NEFROVID2010

Details and patient eligibility

About

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.

Enrollment: 174 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 3 patient groups

Habitual medication withuot additional

No Intervention group

Treatment:

Drug: Habitual medication

Habitual medication plus Hidroferol®

Active Comparator group

Treatment:

Drug: Hidroferol®

Habitual medication plus Zemplar®

Active Comparator group

Treatment:

Drug: Paricalcitol: Zemplar®