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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Hospital Universitario de Canarias.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario de Canarias
ClinicalTrials.gov Identifier:
NCT01442272
First received: September 26, 2011
Last updated: May 18, 2012
Last verified: September 2011
  Purpose

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 Intervention Phase
Kidney Failure, Chronic
Disorder of Vitamin D
Drug: Hidroferol®
Drug: Paricalcitol: Zemplar®
Drug: Habitual medication
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hospital Universitario de Canarias:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 174
Study Start Date: January 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hospital Universitario de Canarias
ClinicalTrials.gov Identifier: NCT01442272     History of Changes
Other Study ID Numbers: NEFROVID2010
Study First Received: September 26, 2011
Last Updated: May 18, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Avitaminosis
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcifediol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 16, 2014