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Status unknownNCT01442272NEFROVID2010Updated May 21, 2012

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

A Phase 4 interventional study of Hidroferol® and Paricalcitol: Zemplar® in Kidney Failure, Chronic and Disorder of Vitamin D, sponsored by Hospital Universitario de Canarias. Status unknown at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-21.

Sponsored by Hospital Universitario de Canarias · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
174
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Kidney Failure, Chronic
  • Disorder of Vitamin D
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's planned enrollment of 174 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Hospital Universitario de Canarias is the lead sponsor of 30 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
174 participants (estimated)

Study arms

  • No intervention
    Habitual medication withuot additional

    Drug: Habitual medication

  • Active comparator
    Habitual medication plus Hidroferol®

    Drug: Hidroferol®

  • Active comparator
    Habitual medication plus Zemplar®

    Drug: Paricalcitol: Zemplar®

Interventions

  • DrugHidroferol®

    Hidroferol® drinkable ampoule in oral solution, 266 mcg (1 drinkable ampoule) each 15 days during 12 months

    Also known as: B

  • DrugParicalcitol: Zemplar®

    Paricalcitol (Zemplar®) oral capsule , 1 mcg (1 capsule)each 24 hours during 12 months

    Also known as: C

  • DrugHabitual medication

    Habitual medication

    Also known as: A

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

2 of 2 sites recruiting
  • Hospital Universitario de Canarias
    La Laguna, S/C Tenerife 38320, Spain
    • Ana Aldea · Contact · a.aldea@gmail.com · +34922678115
    • Victor Lorenzo · Principal investigator
    Recruiting
  • HUC
    La Laguna, S/c Tenerife 38320, Spain
    • ANA ALDEA · Contact · a.aldea@gmail.com · +34922678115
    • Victor Lorenzo · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01442272
Lead sponsor
Hospital Universitario de Canarias
Responsible party
Sponsor
First posted
Sep 28, 2011
Start date
Jan 2012
Primary completion
Oct 2012 (estimated)
Completion
Oct 2013 (estimated)
Last update
May 21, 2012

Study contacts

Ana Aldea
Contact
a.aldea@gmail.com
+34922678115

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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