Chronic Kidney DiseaseNCT00374712
Klotho Gene Polymorphism in Dialyzed Patients With Hyperphosphatemia
An observational study of Chronic Kidney Disease and End Stage Renal Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Patients with chronic kidney disease (CKD) and those with end-stage renal disease (ESRD) undergoing renal replacement therapies show elevated serum phosphate levels which predispose them to cardiovascular calcifications and high risks of death from cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease, End Stage Renal Disease, Hyperphosphatemia
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2005to Nov 2007
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult, end-stage renal disease patients treated by standard hemodialysis
Who may be able to join
- Group 1
- Stable hemodialysis patients for at least 3 months
- Phosphatemia > 2.5 mM
- Kt/V > 1.2
- Total weekly phosphate removal > 75 millimoles
- Group 2
Show all 10Show fewer
- Stable hemodialysis patients for at least 3 months
- Phosphatemia < 1.5 mM
- Kt/V > 1.2
- Total weekly phosphate removal > 25 millimoles
Who cannot join
- Age > 80 years
- Insufficient dialysis dose (Kt/V < 1.2)
- Total weekly phosphate removal < 25 mM
- Problems with vascular access for hemodialysis (central catheter, arteriovenous [A-V] fistula dysfunction)
- Methods of dialysis different than the classical hemodialysis (peritoneal, hemofiltration, or hemodiafiltration with or without acetate)
- Intolerance or allergy to ARYLANE M9 dialyzers
Show all 20Show fewer
- Hypocalcemia < 2.0 mmol/liter
- Hypophosphatemia < 0.6 mmol/liter
- Daily protein intake < 0.6 g/kg/j
- Parathyroidectomy at least 3 months prior to the study
- Evolutive neoplasia with or without secondary lytic bone lesions
- Intestinal malabsorption
- Alcoholism
- Corticotherapy
- Treatment by bisphosphonates, fluor or recombinant PTH
- Malnutrition (body mass index [BMI] < 15)
- Amputation of lower members (> 10% of total body)
- Prolonged immobilization
- Secondary hyperparathyroidism (PTH > 1400 pg/ml)
- Vitamin D deficiency (25OHD3 < 10 ng/ml)
Trial locations and contacts
1 site in 1 country.
France1 site
Clinique de l'Orangerie - Service de Néphrologie et Dialyse
Aubervilliers, 93300
About this study
Official title: Study of Klotho Gene Polymorphisms in the Regulation of Serum Phosphate Levels in Hemodialysis Patients
Patients with chronic kidney disease (CKD) and those with end-stage renal disease (ESRD) undergoing renal replacement therapies show elevated serum phosphate levels which predispose them to cardiovascular calcifications and high risks of death from cardiovascular diseases. However, in certain patients hyperphosphatemia is not related to dialysis insufficiency, excessive daily dietary phosphorus intake or high serum parathyroid hormone (PTH) levels, suggesting that other mechanisms could be involved. Transgenic mice lacking the klotho gene showed a phenotype which resembles that of dialyzed ESRD patients, in the sense that they have hyperphosphatemia, vascular calcifications, and a short lifespan. This study will analyze whether functional polymorphisms or variants in the human klotho gene are associated with hyperphosphatemia in these patients.
Read the detailed description
The entire coding region of the klotho gene will be sequenced looking for functional variants and polymorphisms that differentiate two groups of adult dialyzed ESRD patients, matched for age and gender, and with comparable values for dialysis dose and daily protein intake. These two groups consist of one group of 20 adult, dialyzed patients with serum phosphate levels > 2.50 mM compared to another group of 20 adult, dialyzed ESRD patients with serum phosphate levels < 1.50 mM. The results of this study will allow to determine whether there is a relationship between extreme hyperphosphatemia and klotho gene polymorphisms in dialysed ESRD patients.
- Keywords
- Phosphate, Dialysis, Klotho, Hemodialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Hyperphosphatemia, Chronic Kidney Disease-Mineral and Bone Disorder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2006 (estimated)
- Study startJan 2005
- Study completionNov 2007
Why it stopped: terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Pablo URENA TORRES, MD, Principal investigator, Clinique de l'Orangerie, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374712
- Sponsor's protocol ID
- P031010
- Other IDs
- CRC 03161
- Status last verified
- Nov 2007
- First submitted
- 12 Sep 2005
- Last updated
- 8 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Prie D, Beck L, Urena P, Friedlander G. Recent findings in phosphate homeostasis. Curr Opin Nephrol Hypertens. 2005 Jul;14(4):318-24. doi: 10.1097/01.mnh.0000172716.41853.1e.
PubMed 15930998
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Klotho Gene Polymorphisms in the Regulation of Serum Phosphate Levels in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00374712
- Acronym / sponsor ID
- P031010
- Keywords
- Phosphate, Dialysis, Klotho, Hemodialysis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: terminated
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Jan 2005
- Study completion
- Nov 2007 (actual)
- First posted
- 11 Sep 2006 (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 chronic kidney disease (CKD) and those with end-stage renal disease (ESRD) undergoing renal replacement therapies show elevated serum phosphate levels which predispose them to cardiovascular calcifications and high risks of death from cardiovascular diseases. However, in certain patients hyperphosphatemia is not related to dialysis insufficiency, excessive daily dietary phosphorus intake or high serum parathyroid hormone (PTH) levels, suggesting that other mechanisms could be involved. Transgenic mice lacking the klotho gene showed a phenotype which resembles that of dialyzed ESRD patients, in the sense that they have hyperphosphatemia, vascular calcifications, and a short lifespan. This study will analyze whether functional polymorphisms or variants in the human klotho gene are associated with hyperphosphatemia in these patients.
Detailed description
The entire coding region of the klotho gene will be sequenced looking for functional variants and polymorphisms that differentiate two groups of adult dialyzed ESRD patients, matched for age and gender, and with comparable values for dialysis dose and daily protein intake. These two groups consist of one group of 20 adult, dialyzed patients with serum phosphate levels > 2.50 mM compared to another group of 20 adult, dialyzed ESRD patients with serum phosphate levels < 1.50 mM. The results of this study will allow to determine whether there is a relationship between extreme hyperphosphatemia and klotho gene polymorphisms in dialysed ESRD patients.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, end-stage renal disease patients treated by standard hemodialysis
Key inclusion criteria (10 listed)
- Group 1
- Stable hemodialysis patients for at least 3 months
- Phosphatemia > 2.5 mM
- Kt/V > 1.2
- Total weekly phosphate removal > 75 millimoles
Key exclusion criteria (20 listed)
- Age > 80 years
- Insufficient dialysis dose (Kt/V < 1.2)
- Total weekly phosphate removal < 25 mM
- Problems with vascular access for hemodialysis (central catheter, arteriovenous [A-V] fistula dysfunction)
- Methods of dialysis different than the classical hemodialysis (peritoneal, hemofiltration, or hemodiafiltration with or without acetate)
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2007.
- Results publication: PubMed 15930998Prie D, Beck L, Urena P, Friedlander G. Recent findings in phosphate homeostasis. Curr Opin Nephrol Hypertens. 2005 Jul;14(4):318-24. doi: 10.1097/01.mnh.0000172716.41853.1e.
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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.
Pablo URENA TORRES, MD principal investigator
Clinique de l'Orangerie, France
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 End Stage Renal Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 10 inclusion and 20 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: stopped early, as of the sponsor's last update on 8 Nov 2007. 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 France. 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?
The study was stopped early (reason given: terminated). Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00374712, which also lists 1 linked publication.
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 8 Nov 2007.