NCT01231438

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

October 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

November 9, 2012

Status Verified

November 1, 2012

Enrollment Period

5 months

First QC Date

October 29, 2010

Last Update Submit

November 8, 2012

Conditions

Kidney Failure

Keywords

Renal failure stage 3B

Outcome Measures

Primary Outcomes (1)

  • FGF23 serum level

    Change over 2 weeks of treatment

Secondary Outcomes (5)

  • Calcium serum level

    Change over 2 weeks of therapy

  • Phosphate serum level

    Change over 2 weeks of therapy

  • CTX-1 serum level

    Change over 2 weeks of therapy

  • PINP serum level

    Change over 2 weeks of therapy

  • PTH serum level

    Change over 2 weeks of therapy

Study Arms (2)

Renvela

EXPERIMENTAL

Treatment for 2 weeks

Drug: Renvela

Etalpha

EXPERIMENTAL

Vit D Treatment for 2 weeks

Drug: Etalpha

Interventions

RenvelaDRUG

800mg t.i.d. over 2 weeks

Also known as: Sevelamercarbonate
Renvela
EtalphaDRUG

0.25ug o.d. for 2 weeks

Also known as: Alfakalsidol
Etalpha

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oslo Universitetssykehus Rikshospitalet

Oslo, NO-0372, Norway

Location

Stavanger University Hospital

Stavanger, NO-4011, Norway

Location

Related Publications (2)

  • 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.

    PMID: 22742720RESULT

  • Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

    PMID: 40576086DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Sevelameralfacalcidol

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PolyaminesAminesOrganic Chemicals

Study Officials

  • Lasse Göransson, MD PhD

    Helse Stavanger HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2010

First Posted

November 1, 2010

Study Start

October 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

November 9, 2012

Record last verified: 2012-11

Locations

NO(2)