NCT01442272

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
174

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

May 21, 2012

Status Verified

September 1, 2011

Enrollment Period

9 months

First QC Date

September 26, 2011

Last Update Submit

May 18, 2012

Conditions

Kidney Failure, ChronicDisorder of Vitamin D

Outcome Measures

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.

    1-3 month

Study Arms (3)

Habitual medication withuot additional

NO INTERVENTION
Drug: Habitual medication

Habitual medication plus Hidroferol®

ACTIVE COMPARATOR
Drug: Hidroferol®

Habitual medication plus Zemplar®

ACTIVE COMPARATOR
Drug: Paricalcitol: Zemplar®

Interventions

Hidroferol®DRUG

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

Also known as: B
Habitual medication plus Hidroferol®
Paricalcitol: Zemplar®DRUG

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

Also known as: C
Habitual medication plus Zemplar®
Habitual medicationDRUG

Habitual medication

Also known as: A
Habitual medication withuot additional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario de Canarias

San Cristóbal de La Laguna, S/C Tenerife, 38320, Spain

RECRUITING

HUC

San Cristóbal de La Laguna, S/c Tenerife, 38320, Spain

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Calcifediolparicalcitol

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Central Study Contacts

Ana Aldea

CONTACT

+34922678115a.aldea@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2011

First Posted

September 28, 2011

Study Start

January 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2013

Last Updated

May 21, 2012

Record last verified: 2011-09

Locations

ES(2)