Renal Insufficiency, ChronicNCT00313430
Urinary Concentration and Diluting Ability in Patients With Chronic Renal Disease and/ or Hypertension
An observational study of Renal Insufficiency, Chronic and Hypertension, run by Erling Bjerregaard Pedersen at 1 site in Denmark.
Trial summary
The investigators want to test the hypothesis that patients with chronic renal disease have a poorer ability to preserve water after being thirsty and a poorer ability to excrete water after a load of fluid. They presume that these abilities become poorer when renal insufficiency progresses. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Insufficiency, Chronic, Hypertension
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- May 2004to Mar 2008
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy participants were recruited by advertisements in public and private institutions Patients with primary hypertension or chronic renal failure were recruited from the Out-patients' Clinic, Department of Medicine, Section of Nephrology, Holstebro Hospital
Who may be able to join
- Patients with chronic renal insufficiency, aged between 18 and 65, both men and women
- Creatinine clearance between 30-59 ml/min
- Patients with hypertension, aged between 18 and 65, both men and women; hypertension is defined as a mean arterial blood pressure in the daytime that is more than 140/90 mm Hg.
- Healthy volunteers, aged between 18 and 65, both men and women
Who cannot join
- Clinical signs or history of disease in the heart, lungs, liver, brain, and endocrine organs
- Cancer
- Alcohol abuse
- Medicine abuse
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Medicine, Holstebro Hospital
Holstebro, Ringkjoebing, 7500
About this study
Official title: Urinary Concentration and Diluting Ability in Patients With Chronic Renal Disease or Hypertension
The investigators want to test the hypothesis that patients with chronic renal disease have a poorer ability to preserve water after being thirsty and a poorer ability to excrete water after a load of fluid. They presume that these abilities become poorer when renal insufficiency progresses. The investigators further hypothesize that patients with hypertension also have a decreased ability to concentrate and dilute urine.
- Conditions
- Renal Insufficiency, Chronic, Hypertension
- Keywords
- Urine concentration ability, chronic renal insufficiency, hypertension, aquaporin2, Patients with chronic renal insufficiency, Patients with hypertension, Healthy volunteers
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
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 |
|---|---|---|
| Dialysis patients | Not described | |
| with or wthout glucose added to dialysis fluid | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startMay 2004
- Primary completionMar 2008
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 Renal Insufficiency, ChronicStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erling Bjerregaard Pedersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erling Bjerregaard Pedersen, Regional Hospital Holstebro
- Investigators
- Erling B Pedersen, Professor, Study chair, Holstebro, Holstebro, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313430
- Sponsor's protocol ID
- MED. RES.HOS 2004 03/IT
- Status last verified
- Aug 2015
- First submitted
- 11 Apr 2006
- Last updated
- 21 Aug 2015
- Results posted
- No
Publications
Pedersen EB, Thomsen IM, Lauridsen TG. Abnormal function of the vasopressin-cyclic-AMP-aquaporin2 axis during urine concentrating and diluting in patients with reduced renal function. A case control study. BMC Nephrol. 2010 Oct 5;11:26. doi: 10.1186/1471-2369-11-26.
PubMed 20923561
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Concentration and Diluting Ability in Patients With Chronic Renal Disease or Hypertension
- ClinicalTrials.gov ID
- NCT00313430
- Acronym / sponsor ID
- MED. RES.HOS 2004 03/IT
- Conditions
- Renal Insufficiency, Chronic, Hypertension
- Keywords
- Urine concentration ability, chronic renal insufficiency, hypertension, aquaporin2, Patients with chronic renal insufficiency, Patients with hypertension, Healthy volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Erling Bjerregaard PedersenUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Mar 2008 (actual)
- First posted
- 12 Apr 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.
The investigators want to test the hypothesis that patients with chronic renal disease have a poorer ability to preserve water after being thirsty and a poorer ability to excrete water after a load of fluid. They presume that these abilities become poorer when renal insufficiency progresses. The investigators further hypothesize that patients with hypertension also have a decreased ability to concentrate and dilute urine.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dialysis patients | – | – |
| with or wthout glucose added to dialysis fluid | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy participants were recruited by advertisements in public and private institutions Patients with primary hypertension or chronic renal failure were recruited from the Out-patients' Clinic, Department of Medicine, Section of Nephrology, Holstebro Hospital
Key inclusion criteria (4 listed)
- Patients with chronic renal insufficiency, aged between 18 and 65, both men and women
- Creatinine clearance between 30-59 ml/min
- Patients with hypertension, aged between 18 and 65, both men and women; hypertension is defined as a mean arterial blood pressure in the daytime that is more than 140/90 mm Hg.
- Healthy volunteers, aged between 18 and 65, both men and women
Key exclusion criteria (5 listed)
- Clinical signs or history of disease in the heart, lungs, liver, brain, and endocrine organs
- Cancer
- Alcohol abuse
- Medicine abuse
- Pregnancy
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 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 21 Aug 2015.
- Derived from this study: PubMed 20923561Pedersen EB, Thomsen IM, Lauridsen TG. Abnormal function of the vasopressin-cyclic-AMP-aquaporin2 axis during urine concentrating and diluting in patients with reduced renal function. A case control study. BMC Nephrol. 2010 Oct 5;11:26. doi: 10.1186/1471-2369-11-26.
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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.
Erling B Pedersen, Professor study chair
Holstebro, Holstebro, Denmark
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 Renal Insufficiency, Chronic and Hypertension, run by Erling Bjerregaard Pedersen at 1 site in Denmark.
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 5 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 21 Aug 2015. 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 Denmark. 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00313430, 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 21 Aug 2015.