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

Kidney Failure, Chronic Clinical Trial

— NEFROVID2010  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01442272
• Other study ID #: NEFROVID2010
• Status: Recruiting
• Phase: Phase 4
• First received: September 26, 2011
• Last updated: May 18, 2012
• Start date: January 2012
• Est. completion date: October 2013

Study information

• Verified date: September 2011
• Source: Hospital Universitario de Canarias
• Contact: Ana Aldea
• Phone: +34922678115
• Email: a.aldea[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: October 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Avitaminosis
• Disorder of Vitamin D
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Hidroferol®
Hidroferol® drinkable ampoule in oral solution, 266 mcg (1 drinkable ampoule) each 15 days during 12 months
• Paricalcitol: Zemplar®
Paricalcitol (Zemplar®) oral capsule , 1 mcg (1 capsule)each 24 hours during 12 months
• Habitual medication
Habitual medication

Locations

Country	Name	City	State
Spain	Hospital Universitario de Canarias	La Laguna	S/C Tenerife
Spain	HUC	La Laguna	S/c Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario de Canarias

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes