Chronic Kidney DiseaseCREAM 1NCT00698360
Circadian Rhythm of Erythropoietin And Melatonin in Renal Disease
An observational study of Chronic Kidney Disease, run by Meander Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Investigation of the circadian rhythm of erythropoietin and melatonin in patients with various degrees of renal insufficiency Objectives: Primary objective: Is there a circadian rhythm of epo and melatonin in patients with various degrees of renal insufficiency? Primary Objective: Is there a circadian… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2007to Jun 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with various degrees of renal insufficiency, admitted to Meander Medical Center * A: Patients with renal insufficiency (clearance 10-30 ml/min) * B: Patients with renal insufficiency (clearance 30-60 ml/min) * C: Patients with renal insufficiency (clearance 60-80 ml/min) * D: Patients with normal renal function (clearance > 80 ml/min)
Who may be able to join
- Patient with various degrees of renal insufficiency, stable creatinin clearance: minimum 10 ml/min (measured with MDRD), admitted to our hospital
- Informed Consent
- Man/Women between 18 and 85 years
- Understanding and knowledge of the dutch language
Who cannot join
- Instable angina pectoris, heart failure NYHA class IV
- Therapy with erythropoetin, melatonin and hypnotics
- Acute renal failure or rapidly progressive glomerulonephritis
- Bleeding or hemolysis as a cause of anemia
- Deficiency of iron, folate and/or vitamin B12
- Presence of chronic inflammatory disease or clinically significant infection
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- Hemoglobinopathies
- Alcohol and/or drug abuse
- Enrolment in another study
- Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Circadian Rhythm of Erythropoietin and Melatonin in Patients With Various Degrees of Renal Insufficiency
Rationale: Investigation of the circadian rhythm of erythropoietin and melatonin in patients with various degrees of renal insufficiency
Objectives:
Read more
Primary objective: Is there a circadian rhythm of epo and melatonin in patients with various degrees of renal insufficiency?
Primary Objective: Is there a circadian rhythm of epo and melatonin in patients with various degrees of renal insufficiency compared to patients with a normal renal function?
Secondary Objective: Is there a circadian rhythm of cortisol and IGF in patients with various degrees of renal insufficiency?
Secondary Objective: Is there a circadian rhythm of cortisol and IGF in patients with various degrees of renal insufficiency compared to patients with a normal renal function?
Study design: Comparative study in 4 groups with various degrees of renal insufficiency, duration for each patient 24 hrs. Total duration of study 12 months, patients admitted to the hospital (on nursing ward)
Study population: Patients with various degrees of renal insufficiency
Main study parameters/endpoints: Analysis of the existence of a circadian rhythm in patients with a normal renal function and in patients with variable degrees of renal insufficiency
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Better knowledge of the circadian rhythm in renal insufficiency. This could lead to a more efficient administration of erythropoietin and melatonin in the future.
Extent of burden is 1 venapunction for placement of infusion needle, the withdrawal of 11 times 5 ml blood in 24 hrs, continuous measurement of body temperature via capsule, 24-hour continuous ambulant blood pressure monitoring.
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease, melatonin, erythropoietin, circadian rhythm
- Medical subject headings
- Renal Insufficiency, Chronic
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 |
|---|---|---|
| A | MDRD 10-30 | |
| B | MDRD 30-60 | |
| C | MDRD 60-80 | |
| D | MDRD > 80 |
What is being measured
The primary outcome is the main question the study is designed to answer.
existence of circadian rhythm of Erythropoietin and Melatonin
Measured: 24 hours
Secondary outcomes (2)
existence of a circadian rhythm of cortisol and IGF-1
Measured: 24 hours
Relationship between temperature and melatonin. Relationship between blood pressure and erythropoietin
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startJul 2007
- Primary completionJun 2008
- Study completionJun 2008
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meander Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Bijstand, Meander Medical Center, Hoffmann-La Roche
- Investigators
- Carlo AJM Gaillard, MD PhD, Study chair, Meander Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698360
- Sponsor's protocol ID
- CREAM 1
- Other IDs
- R-07.03M
- Acronym
- CREAM 1
- Status last verified
- Jun 2008
- First submitted
- 13 Jun 2008
- Last updated
- 17 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Rhythm of Erythropoietin and Melatonin in Patients With Various Degrees of Renal Insufficiency
- ClinicalTrials.gov ID
- NCT00698360
- Acronym / sponsor ID
- CREAM 1 / CREAM 1
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease, melatonin, erythropoietin, circadian rhythm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Meander Medical CenterUniversity, hospital or other
- Collaborators
- Stichting Bijstand, Meander Medical Center, Hoffmann-La Roche
- Study start
- Jul 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 17 Jun 2008 (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.
Rationale: Investigation of the circadian rhythm of erythropoietin and melatonin in patients with various degrees of renal insufficiency
Objectives:
Primary objective: Is there a circadian rhythm of epo and melatonin in patients with various degrees of renal insufficiency?
Primary Objective: Is there a circadian rhythm of epo and melatonin in patients with various degrees of renal insufficiency compared to patients with a normal renal function?
Secondary Objective: Is there a circadian rhythm of cortisol and IGF in patients with various degrees of renal insufficiency?
Secondary Objective: Is there a circadian rhythm of cortisol and IGF in patients with various degrees of renal insufficiency compared to patients with a normal renal function?
Study design: Comparative study in 4 groups with various degrees of renal insufficiency, duration for each patient 24 hrs. Total duration of study 12 months, patients admitted to the hospital (on nursing ward)
Study population: Patients with various degrees of renal insufficiency
Main study parameters/endpoints: Analysis of the existence of a circadian rhythm in patients with a normal renal function and in patients with variable degrees of renal insufficiency
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Better knowledge of the circadian rhythm in renal insufficiency. This could lead to a more efficient administration of erythropoietin and melatonin in the future.
Extent of burden is 1 venapunction for placement of infusion needle, the withdrawal of 11 times 5 ml blood in 24 hrs, continuous measurement of body temperature via capsule, 24-hour continuous ambulant blood pressure monitoring.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | – | –MDRD 10-30 |
| B | – | –MDRD 30-60 |
| C | – | –MDRD 60-80 |
| D | – | –MDRD > 80 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with various degrees of renal insufficiency, admitted to Meander Medical Center * A: Patients with renal insufficiency (clearance 10-30 ml/min) * B: Patients with renal insufficiency (clearance 30-60 ml/min) * C: Patients with renal insufficiency (clearance 60-80 ml/min) * D: Patients with normal renal function (clearance > 80 ml/min)
Key inclusion criteria (4 listed)
- Patient with various degrees of renal insufficiency, stable creatinin clearance: minimum 10 ml/min (measured with MDRD), admitted to our hospital
- Informed Consent
- Man/Women between 18 and 85 years
- Understanding and knowledge of the dutch language
Key exclusion criteria (10 listed)
- Instable angina pectoris, heart failure NYHA class IV
- Therapy with erythropoetin, melatonin and hypnotics
- Acute renal failure or rapidly progressive glomerulonephritis
- Bleeding or hemolysis as a cause of anemia
- Deficiency of iron, folate and/or vitamin B12
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
existence of circadian rhythm of Erythropoietin and Melatonin
Time frame: 24 hours
2 secondary outcomes
existence of a circadian rhythm of cortisol and IGF-1
Time frame: 24 hours
Relationship between temperature and melatonin. Relationship between blood pressure and erythropoietin
Time frame: 24 hours
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 17 Jun 2008.
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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.
Carlo AJM Gaillard, MD PhD study chair
Meander 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 Meander Medical Center at 1 site in Netherlands.
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 10 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 17 Jun 2008. 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 Netherlands. 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.
What does the primary outcome measure?
existence of circadian rhythm of Erythropoietin and Melatonin (time frame: 24 hours). It is what the study was designed to measure, not a finding.
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 17 Jun 2008.