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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 18, 2014