Chronic Kidney DiseaseNCT01382966
Serum Sclerostin Levels, Cardiovascular Parameters and Carpal Tunnel Syndrome in Maintenance Hemodialysis Patients
An observational study of Chronic Kidney Disease and Renal Osteodystrophy, run by RFM Renal Treatment Services at 1 site in Turkey (Türkiye).
Trial summary
Sclerostin, the product of the SOST gene, located on chromosome 17, locus q11.2 in humans, was originally believed to be a non-classical Bone morphogenetic protein (BMP) antagonist.Sclerostin was recently identified as a component of parathyroid hormone (PTH) signal transduction. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Renal Osteodystrophy, Left Ventricular Hypertrophy
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2011to Oct 2011
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Maintenance hemodialysis patients (minimum 6 months of duration) No infection, malignancy and autoimmune disease Age> 18 years
Who may be able to join
- Maintenance hemodialysis patients (minimum 6 months of duration)
- Willingness
- Age > 18 years
Who cannot join
- Infection
- Malignancy
- Autoimmune disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Rfm Renal Tedavi Merkezi
Ankara, Ankara, 06810
FAHRİ MANDIROĞLU, MD, +903123176065, fmoglu@hotmail.com
ALPER KIRKPANTUR, MD
About this study
Official title: The Association of Serum Sclerostin Levels,Echocardiographic Parameters, Arteriovenous Fistula Thrombosis and Carpal Tunnel Syndrome in Maintenance Hemodialysis Patients
Sclerostin, the product of the SOST gene, located on chromosome 17, locus q11.2 in humans, was originally believed to be a non-classical Bone morphogenetic protein (BMP) antagonist.Sclerostin was recently identified as a component of parathyroid hormone (PTH) signal transduction.
Chronic kidney disease (CKD) is associated with abnormalities in bone and mineral metabolism.New advances in the pathogenesis of renal osteodystrophy (ROD) change the perspective from which many of its features and treatment are viewed. Calcium, phosphate, parathyroid hormone (PTH), and vitamin D have been shown to be important determinants of survival associated with kidney diseases. Now ROD dependent and independent of these factors is linked to survival more than just skeletal frailty.Furthermore, ROD is shown to be an underappreciated factor in the level of the serum phosphorus in CKD. The discovery and the elucidation of the mechanism of hyperphosphatemia as a cardiovascular risk in CKD change the view of ROD.
Read more
Emerging current data suggests a promising role for serum measurements of sclerostin in addition to iPTH in the diagnosis of high bone turnover in chronic kidney disease-5D patients (dialysis patients).
Because of the close relationship between ROD and cardiovascular disease, the aim of this study is to investigate the association between sclerostin, arteriovenous fistula thrombosis, echocardiography and carpal tunnel syndrome in maintenance hemodialysis patients.
Read the detailed description
Sclerostin, the product of the SOST gene, located on chromosome 17, locus q11.2 in humans, was originally believed to be a non-classical Bone morphogenetic protein (BMP) antagonist.More recently Sclerostin has been identified as binding to LRP5/6 receptors and inhibiting the Wnt signalling pathway .Wnt activation under these circumstances is antagonistic to bone formation. Although the underlying mechanisms are unclear, it is believed that the antagonism of BMP-induced bone formation by sclerostin is mediated by Wnt signalling, but not BMP signalling pathways.
Sclerostin is produced by the osteocyte and has catabolic effects on bone formation. This protein, with a length of 113 residues, has a dssp secondary structure that is 28% beta sheet (6 strands; 32 residues. Sclerostin has an inhibitory effect on the lifetime of the osteoblast. Sclerostin production by osteocytes is inhibited by parathyroid hormone, mechanical loading and cytokines including oncostatin M, cardiotrophin-1 and leukemia inhibitory factor. Sclerostin production is increased by calcitonin. Thus, osteoblast activity is self regulated by a negative feedback system.Sclerostin was recently identified as a component of parathyroid hormone (PTH) signal transduction.
Chronic kidney disease (CKD) is associated with abnormalities in bone and mineral metabolism.Renal osteodystrophy (ROD) is one of the three components of chronic kidney disease-mineral and bone disorder (CKD-MBD. Patients with CKD may develop various types of bone disease, spanning the spectrum of extreme situations such as severe osteitis fibrosa, osteomalacia, mixed osteopathy, and adynamic bone disease. In addition, patients may have osteoporosis, which increases the risk for fractures, both in advanced and in less severe CKD stages (2- 4),which, in turn, result in excess mortality New advances in the pathogenesis of renal osteodystrophy (ROD) change the perspective from which many of its features and treatment are viewed. Calcium, phosphate, parathyroid hormone (PTH), and vitamin D have been shown to be important determinants of survival associated with kidney diseases. Now ROD dependent and independent of these factors is linked to survival more than just skeletal frailty.Furthermore, ROD is shown to be an underappreciated factor in the level of the serum phosphorus in CKD. The discovery and the elucidation of the mechanism of hyperphosphatemia as a cardiovascular risk in CKD change the view of ROD. Emerging current data suggests a promising role for serum measurements of sclerostin in addition to iPTH in the diagnosis of high bone turnover in chronic kidney disease-5D patients (dialysis patients).
The demonstration that the level of serum sclerostin,which is directly produced by osteocytes, is a good predictor for bone formation in patients with CKD may be of clinical interest.Because of the close relationship between ROD and cardiovascular disease, the aim of this study is to investigate the association between sclerostin, arteriovenous fistula thrombosis, echocardiography and carpal tunnel syndrome in maintenance hemodialysis patients.
- Keywords
- sclerostin, arteriovenous fistula thrombosis, carpal tunnel syndrome, echocardiography
- Medical subject headings
- Renal Insufficiency, Chronic, Chronic Kidney Disease-Mineral and Bone Disorder, Hypertrophy, Left Ventricular, Sclerosteosis, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single group | Maintenance hemodialysis patients of minimal 6 months of hemodialysis duration; free of malignancy, infection and autoimmune disease; age over 18 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with left ventricular hypertrophy or left ventricular dysfunction according to tertiles of the serum sclerostin levels
Measured: 3 months
Secondary outcomes (2)
Number of Participants with arteriovenous fistula thrombosis
Measured: 3 months
Number of Participants with carpal tunnel syndrome according to tertiles of the serum sclerostin levels
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RFM Renal Treatment Services
- Sponsor type
- University, hospital or other
- Investigators
- ALPER KIRKPANTUR, MD, Principal investigator, RFM Renal Treatment Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382966
- Sponsor's protocol ID
- RFM RENAL
- Status last verified
- Jun 2011
- First submitted
- 21 Jun 2011
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Drueke TB, Lafage-Proust MH. Sclerostin: just one more player in renal bone disease? Clin J Am Soc Nephrol. 2011 Apr;6(4):700-3. doi: 10.2215/CJN.01370211. Epub 2011 Mar 24. No abstract available.
PubMed 21441122Cejka D, Herberth J, Branscum AJ, Fardo DW, Monier-Faugere MC, Diarra D, Haas M, Malluche HH. Sclerostin and Dickkopf-1 in renal osteodystrophy. Clin J Am Soc Nephrol. 2011 Apr;6(4):877-82. doi: 10.2215/CJN.06550810. Epub 2010 Dec 16.
PubMed 21164019Cejka D, Jager-Lansky A, Kieweg H, Weber M, Bieglmayer C, Haider DG, Diarra D, Patsch JM, Kainberger F, Bohle B, Haas M. Sclerostin serum levels correlate positively with bone mineral density and microarchitecture in haemodialysis patients. Nephrol Dial Transplant. 2012 Jan;27(1):226-30. doi: 10.1093/ndt/gfr270. Epub 2011 May 25.
PubMed 21613383Kirkpantur A, Balci M, Turkvatan A, Afsar B. Serum sclerostin levels, arteriovenous fistula calcification and 2-years all-cause mortality in prevalent hemodialysis patients. Nefrologia. 2016;36(1):24-32. doi: 10.1016/j.nefro.2015.07.006. Epub 2015 Nov 3.
PubMed 26546060
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Serum Sclerostin Levels,Echocardiographic Parameters, Arteriovenous Fistula Thrombosis and Carpal Tunnel Syndrome in Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01382966
- Acronym / sponsor ID
- RFM RENAL
- Keywords
- sclerostin, arteriovenous fistula thrombosis, carpal tunnel syndrome, echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- RFM Renal Treatment ServicesUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 27 Jun 2011 (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.
Sclerostin, the product of the SOST gene, located on chromosome 17, locus q11.2 in humans, was originally believed to be a non-classical Bone morphogenetic protein (BMP) antagonist.Sclerostin was recently identified as a component of parathyroid hormone (PTH) signal transduction.
Chronic kidney disease (CKD) is associated with abnormalities in bone and mineral metabolism.New advances in the pathogenesis of renal osteodystrophy (ROD) change the perspective from which many of its features and treatment are viewed. Calcium, phosphate, parathyroid hormone (PTH), and vitamin D have been shown to be important determinants of survival associated with kidney diseases. Now ROD dependent and independent of these factors is linked to survival more than just skeletal frailty.Furthermore, ROD is shown to be an underappreciated factor in the level of the serum phosphorus in CKD. The discovery and the elucidation of the mechanism of hyperphosphatemia as a cardiovascular risk in CKD change the view of ROD.
Emerging current data suggests a promising role for serum measurements of sclerostin in addition to iPTH in the diagnosis of high bone turnover in chronic kidney disease-5D patients (dialysis patients).
Because of the close relationship between ROD and cardiovascular disease, the aim of this study is to investigate the association between sclerostin, arteriovenous fistula thrombosis, echocardiography and carpal tunnel syndrome in maintenance hemodialysis patients.
Detailed description
Sclerostin, the product of the SOST gene, located on chromosome 17, locus q11.2 in humans, was originally believed to be a non-classical Bone morphogenetic protein (BMP) antagonist.More recently Sclerostin has been identified as binding to LRP5/6 receptors and inhibiting the Wnt signalling pathway .Wnt activation under these circumstances is antagonistic to bone formation. Although the underlying mechanisms are unclear, it is believed that the antagonism of BMP-induced bone formation by sclerostin is mediated by Wnt signalling, but not BMP signalling pathways.
Sclerostin is produced by the osteocyte and has catabolic effects on bone formation. This protein, with a length of 113 residues, has a dssp secondary structure that is 28% beta sheet (6 strands; 32 residues. Sclerostin has an inhibitory effect on the lifetime of the osteoblast. Sclerostin production by osteocytes is inhibited by parathyroid hormone, mechanical loading and cytokines including oncostatin M, cardiotrophin-1 and leukemia inhibitory factor. Sclerostin production is increased by calcitonin. Thus, osteoblast activity is self regulated by a negative feedback system.Sclerostin was recently identified as a component of parathyroid hormone (PTH) signal transduction.
Chronic kidney disease (CKD) is associated with abnormalities in bone and mineral metabolism.Renal osteodystrophy (ROD) is one of the three components of chronic kidney disease-mineral and bone disorder (CKD-MBD. Patients with CKD may develop various types of bone disease, spanning the spectrum of extreme situations such as severe osteitis fibrosa, osteomalacia, mixed osteopathy, and adynamic bone disease. In addition, patients may have osteoporosis, which increases the risk for fractures, both in advanced and in less severe CKD stages (2- 4),which, in turn, result in excess mortality New advances in the pathogenesis of renal osteodystrophy (ROD) change the perspective from which many of its features and treatment are viewed. Calcium, phosphate, parathyroid hormone (PTH), and vitamin D have been shown to be important determinants of survival associated with kidney diseases. Now ROD dependent and independent of these factors is linked to survival more than just skeletal frailty.Furthermore, ROD is shown to be an underappreciated factor in the level of the serum phosphorus in CKD. The discovery and the elucidation of the mechanism of hyperphosphatemia as a cardiovascular risk in CKD change the view of ROD. Emerging current data suggests a promising role for serum measurements of sclerostin in addition to iPTH in the diagnosis of high bone turnover in chronic kidney disease-5D patients (dialysis patients).
The demonstration that the level of serum sclerostin,which is directly produced by osteocytes, is a good predictor for bone formation in patients with CKD may be of clinical interest.Because of the close relationship between ROD and cardiovascular disease, the aim of this study is to investigate the association between sclerostin, arteriovenous fistula thrombosis, echocardiography and carpal tunnel syndrome in maintenance hemodialysis patients.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | – | –Maintenance hemodialysis patients of minimal 6 months of hemodialysis duration; free of malignancy, infection and autoimmune disease; age over 18 years |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Maintenance hemodialysis patients (minimum 6 months of duration) No infection, malignancy and autoimmune disease Age> 18 years
Key inclusion criteria (3 listed)
- Maintenance hemodialysis patients (minimum 6 months of duration)
- Willingness
- Age > 18 years
Key exclusion criteria (3 listed)
- Infection
- Malignancy
- Autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with left ventricular hypertrophy or left ventricular dysfunction according to tertiles of the serum sclerostin levels
Time frame: 3 months
2 secondary outcomes
Number of Participants with arteriovenous fistula thrombosis
Time frame: 3 months
Number of Participants with carpal tunnel syndrome according to tertiles of the serum sclerostin levels
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
- Background: PubMed 21441122Drueke TB, Lafage-Proust MH. Sclerostin: just one more player in renal bone disease? Clin J Am Soc Nephrol. 2011 Apr;6(4):700-3. doi: 10.2215/CJN.01370211. Epub 2011 Mar 24. No abstract available.
- Background: PubMed 21164019Cejka D, Herberth J, Branscum AJ, Fardo DW, Monier-Faugere MC, Diarra D, Haas M, Malluche HH. Sclerostin and Dickkopf-1 in renal osteodystrophy. Clin J Am Soc Nephrol. 2011 Apr;6(4):877-82. doi: 10.2215/CJN.06550810. Epub 2010 Dec 16.
- Background: PubMed 21613383Cejka D, Jager-Lansky A, Kieweg H, Weber M, Bieglmayer C, Haider DG, Diarra D, Patsch JM, Kainberger F, Bohle B, Haas M. Sclerostin serum levels correlate positively with bone mineral density and microarchitecture in haemodialysis patients. Nephrol Dial Transplant. 2012 Jan;27(1):226-30. doi: 10.1093/ndt/gfr270. Epub 2011 May 25.
- Derived from this study: PubMed 26546060Kirkpantur A, Balci M, Turkvatan A, Afsar B. Serum sclerostin levels, arteriovenous fistula calcification and 2-years all-cause mortality in prevalent hemodialysis patients. Nefrologia. 2016;36(1):24-32. doi: 10.1016/j.nefro.2015.07.006. Epub 2015 Nov 3.
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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.
ALPER KIRKPANTUR, MD principal investigator
RFM Renal Treatment Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Renal Osteodystrophy, run by RFM Renal Treatment Services at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Jun 2011. 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 Turkey (Türkiye). 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with left ventricular hypertrophy or left ventricular dysfunction according to tertiles of the serum sclerostin levels (time frame: 3 months). 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 NCT01382966, which also lists 4 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 28 Jun 2011.