ProteinuriaPhase 3NCT01694160
Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria
A Phase 3 study testing Paricalcitol in people with Proteinuria, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The main objective of this study is to examine if paricalcitol may reduce progression of graft fibrosis and proteinuria in kidney transplant patients. Cyclosporine and tacrolimus have a detrimental long-term effect by inducing graft fibrosis. About 50% of graft losses are related to interstitial fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Proteinuria
- What is being tested?
- Paricalcitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2013to Dec 2015
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- kidney transplant patients
Who cannot join
- Previously transplanted
Trial locations and contacts
1 site in 1 country.
Norway1 site
Renal Section, Oslo University Hospital, Rikshospitalet
Oslo, 0424
About this study
Official title: Consultant in Nephrology. MD., Ph.D.
The main objective of this study is to examine if paricalcitol may reduce progression of graft fibrosis and proteinuria in kidney transplant patients. Cyclosporine and tacrolimus have a detrimental long-term effect by inducing graft fibrosis. About 50% of graft losses are related to interstitial fibrosis. Paricalcitol is a vitamin D receptor activator indicated for treatment of secondary hyperparathyroidism. Paricalcitol is known to exert an anti-inflammatory and antifibrotic and attenuate cyclosporine-induced fibrosis. Paricalcitol is also shown to be renoprotective by reducing proteinuria. No randomized controlled trials with paricalcitol are performed in renal transplant patients examining the effect on proteinuria and graft fibrosis.
Read the detailed description
77 randomized, 37 paricalcitol, 40 no treatment
- Conditions
- Proteinuria
- Being tested
- Paricalcitol
- Keywords
- kidney transplant patients, Albuminuria
- Medical subject headings
- Proteinuria, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParicalcitolDrug
Zemplar (paricalcitol) 2ug daily, oral intake
| Study group | Role | What they receive |
|---|---|---|
| Paricalcitol | Experimental | Paricalcitol 2 ug/daily for 48 weeks Receives: Drug: Paricalcitol |
| no intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in albumin/creatinine ratio from baseline to end of study.
Albumin will be measured in spot urine as albumin/creatinine ratio in mg/mmol. Assuming a type 1 error of 5% and at type II error of 20 %, with a clinically relevant difference in 3.5 mg/mmol from a baseline value of 15.0 + 10 mg/mmol the estimated number of patients in each arm should be 65, assuming a correlation between start and end value of 0.5.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2015
- Study completionDec 2015
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 ProteinuriaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hallvard Holdaas, Oslo University Hospital
- Investigators
- Hallvard Holdaas, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694160
- Sponsor's protocol ID
- 2012/107 D
- Other IDs
- 2012-000429-32
- Status last verified
- Mar 2016
- First submitted
- 23 Sep 2012
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Yes
Publications
Pihlstrom HK, Ueland T, Michelsen AE, Aukrust P, Gatti F, Hammarstrom C, Kasprzycka M, Wang J, Haraldsen G, Mjoen G, Dahle DO, Midtvedt K, Eide IA, Hartmann A, Holdaas H. Exploring the potential effect of paricalcitol on markers of inflammation in de novo renal transplant recipients. PLoS One. 2020 Dec 16;15(12):e0243759. doi: 10.1371/journal.pone.0243759. eCollection 2020.
PubMed 33326471Ussif A, Pihlstrom H, Pasch A, Holdaas H, Hartmann A, Smerud K, Asberg A. Paricalcitol supplementation during the first year after kidney transplantation does not affect calcification propensity score. BMC Nephrol. 2018 Aug 22;19(1):212. doi: 10.1186/s12882-018-1000-8.
PubMed 30134956
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consultant in Nephrology. MD., Ph.D.
- ClinicalTrials.gov ID
- NCT01694160
- Acronym / sponsor ID
- 2012/107 D
- Conditions
- Proteinuria
- Keywords
- kidney transplant patients, Albuminuria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Sep 2012 (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.
The main objective of this study is to examine if paricalcitol may reduce progression of graft fibrosis and proteinuria in kidney transplant patients. Cyclosporine and tacrolimus have a detrimental long-term effect by inducing graft fibrosis. About 50% of graft losses are related to interstitial fibrosis. Paricalcitol is a vitamin D receptor activator indicated for treatment of secondary hyperparathyroidism. Paricalcitol is known to exert an anti-inflammatory and antifibrotic and attenuate cyclosporine-induced fibrosis. Paricalcitol is also shown to be renoprotective by reducing proteinuria. No randomized controlled trials with paricalcitol are performed in renal transplant patients examining the effect on proteinuria and graft fibrosis.
Detailed description
77 randomized, 37 paricalcitol, 40 no treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paricalcitol | Experimental | Drug: ParicalcitolParicalcitol 2 ug/daily for 48 weeks |
| no intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- kidney transplant patients
Key exclusion criteria (1 listed)
- Previously transplanted
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 |
|---|---|---|
| ParicalcitolZemplar (paricalcitol) 2ug daily, oral intake | Drug | Paricalcitol |
Primary outcome
Change in albumin/creatinine ratio from baseline to end of study.
Time frame: 1 year
Albumin will be measured in spot urine as albumin/creatinine ratio in mg/mmol. Assuming a type 1 error of 5% and at type II error of 20 %, with a clinically relevant difference in 3.5 mg/mmol from a baseline value of 15.0 + 10 mg/mmol the estimated number of patients in each arm should be 65, assuming a correlation between start and end value of 0.5.
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 30 Mar 2016.
- Derived from this study: PubMed 33326471Pihlstrom HK, Ueland T, Michelsen AE, Aukrust P, Gatti F, Hammarstrom C, Kasprzycka M, Wang J, Haraldsen G, Mjoen G, Dahle DO, Midtvedt K, Eide IA, Hartmann A, Holdaas H. Exploring the potential effect of paricalcitol on markers of inflammation in de novo renal transplant recipients. PLoS One. 2020 Dec 16;15(12):e0243759. doi: 10.1371/journal.pone.0243759. eCollection 2020.
- Derived from this study: PubMed 30134956Ussif A, Pihlstrom H, Pasch A, Holdaas H, Hartmann A, Smerud K, Asberg A. Paricalcitol supplementation during the first year after kidney transplantation does not affect calcification propensity score. BMC Nephrol. 2018 Aug 22;19(1):212. doi: 10.1186/s12882-018-1000-8.
- Individual participant dataSharing planned: No. Yes
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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.
Hallvard Holdaas, MD, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paricalcitol in people with Proteinuria, run by Oslo University Hospital at 1 site 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 1 inclusion and 1 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 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in albumin/creatinine ratio from baseline to end of study. (time frame: 1 year). 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 NCT01694160, 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 30 Mar 2016.