Back to resultsValue Antiproteinuric Effects From Vitamin D Derivatives in Patient With Chronic Kidney Illness and the Lack of Vitamin D (NEFROVID2010)
Primary Purpose
Kidney Failure, Chronic, Disorder of Vitamin D
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Hidroferol®
Paricalcitol: Zemplar®
Habitual medication
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure, Chronic
Eligibility 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
Sites / Locations
- Hospital Universitario de CanariasRecruiting
- HUCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Habitual medication withuot additional
Habitual medication plus Hidroferol®
Habitual medication plus Zemplar®
Arm Description
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01442272
First Posted
September 26, 2011
Last Updated
May 18, 2012
Sponsor
Hospital Universitario de Canarias
1. Study Identification
Unique Protocol Identification Number
NCT01442272
Brief Title
Value Antiproteinuric Effects From Vitamin D Derivatives in Patient With Chronic Kidney Illness and the Lack of Vitamin D
Acronym
NEFROVID2010
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 Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitario de Canarias
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic, Disorder of Vitamin D
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Habitual medication withuot additional
Arm Type
No Intervention
Arm Title
Habitual medication plus Hidroferol®
Arm Type
Active Comparator
Arm Title
Habitual medication plus Zemplar®
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Hidroferol®
Other Intervention Name(s)
B
Intervention Description
Hidroferol® drinkable ampoule in oral solution, 266 mcg (1 drinkable ampoule) each 15 days during 12 months
Intervention Type
Drug
Intervention Name(s)
Paricalcitol: Zemplar®
Other Intervention Name(s)
C
Intervention Description
Paricalcitol (Zemplar®) oral capsule , 1 mcg (1 capsule)each 24 hours during 12 months
Intervention Type
Drug
Intervention Name(s)
Habitual medication
Other Intervention Name(s)
A
Intervention Description
Habitual medication
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Aldea
Phone
+34922678115
Email
a.aldea@gmail.com
Facility Information:
Facility Name
Hospital Universitario de Canarias
City
La Laguna
State/Province
S/C Tenerife
ZIP/Postal Code
38320
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Aldea
Phone
+34922678115
Email
a.aldea@gmail.com
First Name & Middle Initial & Last Name & Degree
Victor Lorenzo
Facility Name
HUC
City
La Laguna
State/Province
S/c Tenerife
ZIP/Postal Code
38320
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANA ALDEA
Phone
+34922678115
Email
a.aldea@gmail.com
First Name & Middle Initial & Last Name & Degree
Victor Lorenzo
12. IPD Sharing Statement
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Value Antiproteinuric Effects From Vitamin D Derivatives in Patient With Chronic Kidney Illness and the Lack of Vitamin D
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