Kidney FailurePhase 2NCT01231438
Treatment of Early Stage Renal Failure With Active Vitamin D or a Phosphate Binder.
A Phase 2 study testing Renvela and Etalpha in people with Kidney Failure, run by Helse Stavanger HF at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure
- What is being tested?
- Renvela and Etalpha
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesNorway
- Study dates
- Oct 2010to Mar 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Renal failure stage 3B
- 25(OH)vitamin D level above 50 nmol/l
- Age over 18 years
- Written consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Oslo Universitetssykehus Rikshospitalet
Oslo, NO-0372
Stavanger University Hospital
Stavanger, NO-4011
About this study
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.
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.
- Conditions
- Kidney Failure
- Being tested
- Renvela, Etalpha
- Keywords
- Renal failure stage 3B
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenvelaDrug
Also called Sevelamercarbonate
800mg t.i.d. over 2 weeks
EtalphaDrug
Also called Alfakalsidol
0.25ug o.d. for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Renvela | Experimental | Treatment for 2 weeks Receives: Drug: Renvela |
| Etalpha | Experimental | Vit D Treatment for 2 weeks Receives: Drug: Etalpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
FGF23 serum level
Measured: Change over 2 weeks of treatment
Secondary outcomes (5)
Calcium serum level
Measured: Change over 2 weeks of therapy
Phosphate serum level
Measured: Change over 2 weeks of therapy
CTX-1 serum level
Measured: Change over 2 weeks of therapy
PINP serum level
Measured: Change over 2 weeks of therapy
PTH serum level
Measured: Change over 2 weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Rikshospitalet University Hospital
- Responsible party
- Sponsor
- Investigators
- Lasse Göransson, MD PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231438
- Sponsor's protocol ID
- SUS2010GOLA01
- Other IDs
- 2010-020415-36
- Status last verified
- Nov 2012
- First submitted
- 29 Oct 2010
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22742720Natale 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.
PubMed 40576086
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01231438
- Acronym / sponsor ID
- SUS2010GOLA01
- Conditions
- Kidney Failure
- Keywords
- Renal failure stage 3B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Rikshospitalet University Hospital
- Study start
- Oct 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 1 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renvela | Experimental | Drug: RenvelaTreatment for 2 weeks |
| Etalpha | Experimental | Drug: EtalphaVit D Treatment for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Renal failure stage 3B
- 25(OH)vitamin D level above 50 nmol/l
- Age over 18 years
- Written consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RenvelaAlso: Sevelamercarbonate800mg t.i.d. over 2 weeks | Drug | Renvela |
| EtalphaAlso: Alfakalsidol0.25ug o.d. for 2 weeks | Drug | Etalpha |
Primary outcome
FGF23 serum level
Time frame: Change over 2 weeks of treatment
5 secondary outcomes
Calcium serum level
Time frame: Change over 2 weeks of therapy
Phosphate serum level
Time frame: Change over 2 weeks of therapy
CTX-1 serum level
Time frame: Change over 2 weeks of therapy
PINP serum level
Time frame: Change over 2 weeks of therapy
PTH serum level
Time frame: Change over 2 weeks of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
- Results publication: PubMed 22742720Bleskestad 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.
- Derived from this study: PubMed 40576086Natale 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.
Related trials for Kidney Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lasse Göransson, MD PhD principal investigator
Helse Stavanger HF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Renvela and Etalpha in people with Kidney Failure, run by Helse Stavanger HF at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FGF23 serum level (time frame: Change over 2 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01231438, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2012.