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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01442272


Contacts
Contact: Ana Aldea +34922678115 a.aldea@gmail.com

Locations
Spain
Hospital Universitario de Canarias Recruiting
La Laguna, S/C Tenerife, Spain, 38320
Contact: Ana Aldea    +34922678115    a.aldea@gmail.com   
Principal Investigator: Victor Lorenzo         
HUC Recruiting
La Laguna, S/c Tenerife, Spain, 38320
Contact: ANA ALDEA    +34922678115    a.aldea@gmail.com   
Principal Investigator: Victor Lorenzo         
Sponsors and Collaborators
Hospital Universitario de Canarias
More Information

Responsible Party: Hospital Universitario de Canarias
ClinicalTrials.gov Identifier: NCT01442272     History of Changes
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:
Renal Insufficiency
Kidney Failure, Chronic
Avitaminosis
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Calcifediol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents