Chronic Kidney DiseaseNCT01350687
Pulmonary Hypertension Prevention in Hemodialysis
An observational study of Chronic Kidney Disease, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
Trial summary
Pulmonary hypertension is a new complication described in hemodialysis patients. in the last year these patients were treated by calcium carbonate orally to control serum phosphor. Calcium phosphor deposits in pulmonary artery can explain this phenomena. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2011to Jun 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 40 patients on hemodialysis treated with Phosphore biders, non-calcium containig.
Who may be able to join
- Hemodialysis Patients without fistula
Who cannot join
- Heart Disease
Trial locations and contacts
1 site in 1 country.
Israel1 site
Poria Medical Center
Tiberias
Farid Nakhoul, Prof, 97246652587, fnakhoul@poria.health.gov.il
Farid Nakhoul, Prof
About this study
Official title: New Phosphore Binders in Prevention of Pulmonary Hypertension
Pulmonary hypertension is a new complication described in hemodialysis patients. in the last year these patients were treated by calcium carbonate orally to control serum phosphor. Calcium phosphor deposits in pulmonary artery can explain this phenomena. The investigators want to investigate the new phosphor non calcium containing agents in hemodialysis patients and to measure the pulmonary pressure.
Read the detailed description
The investigators will measure pulmonary blood pressure before and after treatment with new phosphor binders, non calcium containing.
- Conditions
- Chronic Kidney Disease
- Keywords
- Calcium Phosphore, Renagel
- Medical subject headings
- Renal Insufficiency, Chronic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Investigators
- Farid Nakhoul, Prof., Study chair, Poria medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350687
- Sponsor's protocol ID
- farid.CTIL
- Status last verified
- Apr 2011
- First submitted
- 8 May 2011
- Last updated
- 10 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Phosphore Binders in Prevention of Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT01350687
- Acronym / sponsor ID
- farid.CTIL
- Conditions
- Chronic Kidney Disease
- Keywords
- Calcium Phosphore, Renagel
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 10 May 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.
Pulmonary hypertension is a new complication described in hemodialysis patients. in the last year these patients were treated by calcium carbonate orally to control serum phosphor. Calcium phosphor deposits in pulmonary artery can explain this phenomena. The investigators want to investigate the new phosphor non calcium containing agents in hemodialysis patients and to measure the pulmonary pressure.
Detailed description
The investigators will measure pulmonary blood pressure before and after treatment with new phosphor binders, non calcium containing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 patients on hemodialysis treated with Phosphore biders, non-calcium containig.
Key inclusion criteria (1 listed)
- Hemodialysis Patients without fistula
Key exclusion criteria (1 listed)
- Heart 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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2011.
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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.
Farid Nakhoul, Prof. study chair
Poria medical Center
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, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 10 May 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 Israel. 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.
Where can I read the original study information?
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 10 May 2011.