Status:
UNKNOWN
Value Antiproteinuric Effects From Vitamin D Derivatives in Patient With Chronic Kidney Illness and the Lack of Vitamin D
Lead Sponsor:
Hospital Universitario de Canarias
Conditions:
Kidney Failure, Chronic
Disorder of Vitamin D
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2013
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT01442272
Start Date
January 1 2012
End Date
October 1 2013
Last Update
May 21 2012
Active Locations (2)
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1
Hospital Universitario de Canarias
San Cristóbal de La Laguna, S/C Tenerife, Spain, 38320
2
HUC
San Cristóbal de La Laguna, S/c Tenerife, Spain, 38320