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

May 18, 2012 updated by: Hospital Universitario de Canarias

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

174

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • S/C Tenerife
      • La Laguna, S/C Tenerife, Spain, 38320
        • Recruiting
        • Hospital Universitario de Canarias
        • Contact:
        • Principal Investigator:
          • Victor Lorenzo
    • S/c Tenerife
      • La Laguna, S/c Tenerife, Spain, 38320
        • Recruiting
        • HUC
        • Contact:
        • Principal Investigator:
          • Victor Lorenzo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Habitual medication withuot additional
Drug: Habitual medication
Habitual medication
Other Names:
  • 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 Names:
  • 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 Names:
  • C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1-3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario de Canarias

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

September 26, 2011

First Submitted That Met QC Criteria

September 27, 2011

First Posted (Estimate)

September 28, 2011

Study Record Updates

Last Update Posted (Estimate)

May 21, 2012

Last Update Submitted That Met QC Criteria

May 18, 2012

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEFROVID2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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