Treatment of Early Stage Renal Failure With Active Vitami... | NCT01231438

Studies
Treatment of Early Stage Renal Failure With Active Vitamin D or a Phosphate Binder.

NCT01231438

Sponsor

Helse Stavanger HF

Status

Completed

Last Update Posted

Nov 9, 2012Estimated

Enrollment

21Actual

Phase

Phase 2

Conditions

Kidney Failure

Interventions

Renvela
Etalpha

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010-020415-36	EudraCT Number

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Oct 29, 2010

First Submission Date that Met QC Criteria

Oct 29, 2010

First Posted Date

Nov 1, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2012

Last Update Posted Date

Nov 9, 2012Estimated

Name	Class
Rikshospitalet University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients with reduced renal function normally develop hyperparathyroidism, which in turn is associated with increased cardiovascular risk and de-calcification. Hyperparathyroidism may be enhanced by an increased level of FGF23 which is often seen in the early stage of renal failure. This pilot study will investigate the FGF23-lowering effect of early initiation of treatment with a phosphate binder versus active vitamin D in an open crossover design.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Renvela	Experimental	Treatment for 2 weeks	Drug: Renvela
Etalpha	Experimental	Vit D Treatment for 2 weeks	Drug: Etalpha

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Renvela	Drug	800mg t.i.d. over 2 weeks	Renvela	Sevelamercarbonate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
FGF23 serum level		Change over 2 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Calcium serum level		Change over 2 weeks of therapy
Phosphate serum level		Change over 2 weeks of therapy
CTX-1 serum level

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Renal failure stage 3B
25(OH)vitamin D level above 50 nmol/l
Age over 18 years
Written consent

Exclusion Criteria:

Major surgery during the previous 6 months
Myocardial infarct during the previous 6 months
Unstable heart failure
Ongoing treatment for any malignancy
History of frequent infections
Pregnancy
Ongoing treatment with steroids, lithium or biphosphonates

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lasse Göransson, MD PhD	Helse Stavanger HF	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo Universitetssykehus Rikshospitalet		Oslo		NO-0372	Norway
Stavanger University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22742720	Result	Bleskestad IH, Bergrem H, Hartmann A, Godang K, Goransson LG. Fibroblast growth factor 23 and parathyroid hormone after treatment with active vitamin D and sevelamer carbonate in patients with chronic kidney disease stage 3b, a randomized crossover trial. BMC Nephrol. 2012 Jun 28;13:49. doi: 10.1186/1471-2369-13-49.
40576086	Derived

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D000069603	Sevelamer
C008088	alfacalcidol

ID	Term
D011073	Polyamines
D000588	Amines
D009930	Organic Chemicals