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

Primary Purpose

Kidney Failure

Status

Completed

Phase

Phase 2

Locations

Norway

Study Type

Interventional

Intervention

Renvela

Etalpha

About this trial

This is an interventional treatment trial for Kidney Failure focused on measuring Renal failure stage 3B

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Oslo Universitetssykehus Rikshospitalet
Stavanger University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Renvela

Etalpha

Arm Description

Treatment for 2 weeks

Vit D Treatment for 2 weeks

Outcomes

Primary Outcome Measures

FGF23 serum level

Secondary Outcome Measures

Calcium serum level

Phosphate serum level

CTX-1 serum level

PINP serum level

PTH serum level

Full Information

NCT ID

NCT01231438

First Posted

October 29, 2010

Last Updated

November 8, 2012

Sponsor

Helse Stavanger HF

Collaborators

Rikshospitalet University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01231438

Brief Title

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

Official Title

An Open, Randomized, Crossover Phase 2 Pilot Study of Treatment of Stage 3B Renal Failure With Active Vitamin D or a Phosphate Binder to Evaluate the Effect on the FGF23 and PTH Levels.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Helse Stavanger HF

Collaborators

Rikshospitalet University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Failure

Keywords

Renal failure stage 3B

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Renvela

Arm Type

Experimental

Arm Description

Treatment for 2 weeks

Arm Title

Etalpha

Arm Type

Experimental

Arm Description

Vit D Treatment for 2 weeks

Intervention Type

Drug

Intervention Name(s)

Renvela

Other Intervention Name(s)

Sevelamercarbonate

Intervention Description

800mg t.i.d. over 2 weeks

Intervention Type

Drug

Intervention Name(s)

Etalpha

Other Intervention Name(s)

Alfakalsidol

Intervention Description

0.25ug o.d. for 2 weeks

Primary Outcome Measure Information:

Title

FGF23 serum level

Time Frame

Change over 2 weeks of treatment

Secondary Outcome Measure Information:

Title

Calcium serum level

Time Frame