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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01442272
Recruitment Status : Unknown
Verified September 2011 by Hospital Universitario de Canarias.
Recruitment status was:  Recruiting
First Posted : September 28, 2011
Last Update Posted : May 21, 2012
Information provided by (Responsible Party):
Hospital Universitario de Canarias

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.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Disorder of Vitamin D Drug: Hidroferol® Drug: Paricalcitol: Zemplar® Drug: Habitual medication Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2012
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Calcifediol

Arm Intervention/treatment
No Intervention: Habitual medication withuot additional Drug: Habitual medication
Habitual medication
Other Name: A

Active Comparator: Habitual medication plus Hidroferol® Drug: Hidroferol®
Hidroferol® drinkable ampoule in oral solution, 266 mcg (1 drinkable ampoule) each 15 days during 12 months
Other Name: B

Active Comparator: Habitual medication plus Zemplar® Drug: Paricalcitol: Zemplar®
Paricalcitol (Zemplar®) oral capsule , 1 mcg (1 capsule)each 24 hours during 12 months
Other Name: C

Primary Outcome Measures :
  1. Protein/creatinine quotient and albumin/creatinine in matinal urine sample: basal and 3 period months after a month of the therapeutic protocol beginning. [ Time Frame: 1-3 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01442272

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Contact: Ana Aldea +34922678115

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Hospital Universitario de Canarias Recruiting
La Laguna, S/C Tenerife, Spain, 38320
Contact: Ana Aldea    +34922678115   
Principal Investigator: Victor Lorenzo         
HUC Recruiting
La Laguna, S/c Tenerife, Spain, 38320
Contact: ANA ALDEA    +34922678115   
Principal Investigator: Victor Lorenzo         
Sponsors and Collaborators
Hospital Universitario de Canarias
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Responsible Party: Hospital Universitario de Canarias Identifier: NCT01442272    
Other Study ID Numbers: NEFROVID2010
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: May 21, 2012
Last Verified: September 2011
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents