Value Antiproteinuric Effects From Vitamin D Derivatives in Patient With Chronic Kidney Illness and the Lack of Vitamin D (NEFROVID2010)
This study is currently recruiting participants.
Verified September 2011 by Hospital Universitario de Canarias
Sponsor:
Hospital Universitario de Canarias
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
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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 May 16, 2013