Chronic Kidney DiseaseNCT00758537
Tryptophan Metabolism in Kidney Disease
An observational study of Chronic Kidney Disease, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Tryptophan metabolism in kidney disease will be investigated in patients with chronic kidney disease stages (ADOQI 3-5). Tryptophan levels and respective catabolites will be assessed under hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Oct 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: tertiary care academic center, university hospital
Who may be able to join
- Chronic kidney disease (for > 3months) stages (National Kidney foundation/ADOQI): 3-5
Who cannot join
- Signs of infection or systemic inflammation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charite University Medicine Berlin
Berlin, State of Berlin, 13353
About this study
Tryptophan metabolism in kidney disease will be investigated in patients with chronic kidney disease stages (ADOQI 3-5). Tryptophan levels and respective catabolites will be assessed under hemodialysis.
- Conditions
- Chronic Kidney Disease
- Keywords
- Assessment of tryptophan and tryptophan catabolites and IDO-activity in patients with chronic kidney disease
- 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 |
|---|---|---|
| Patients with chronic kidney disease stage 3 | Not described | |
| patients with chronic kidney disease stage 4 | Not described | |
| patients with chronic kidney disease stage 5 (ESRD) | Not described | |
| Controls (no kidney disease) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Course of plasma tryptophan level and levels of tryptophan metabolites under standard low-flux hemodialysis.
Measured: does not apply
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startJan 2007
- Study completionOct 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.
- More trials run by Charite University, Berlin, GermanyThe 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Petra Reinke, Md PhD, Principal investigator, Charite University Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758537
- Sponsor's protocol ID
- TRY1STU
- Status last verified
- Jul 2009
- First submitted
- 23 Sep 2008
- Last updated
- 14 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tryptophan Metabolism in Kidney Disease
- ClinicalTrials.gov ID
- NCT00758537
- Acronym / sponsor ID
- TRY1STU
- Conditions
- Chronic Kidney Disease
- Keywords
- Assessment of tryptophan and tryptophan catabolites and IDO-activity in patients with chronic kidney disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Oct 2008
- First posted
- 25 Sep 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.
Tryptophan metabolism in kidney disease will be investigated in patients with chronic kidney disease stages (ADOQI 3-5). Tryptophan levels and respective catabolites will be assessed under hemodialysis.
Study design
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic kidney disease stage 3 | – | – |
| patients with chronic kidney disease stage 4 | – | – |
| patients with chronic kidney disease stage 5 (ESRD) | – | – |
| Controls (no kidney disease) | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- tertiary care academic center, university hospital
Key inclusion criteria (1 listed)
- Chronic kidney disease (for > 3months) stages (National Kidney foundation/ADOQI): 3-5
Key exclusion criteria (1 listed)
- Signs of infection or systemic inflammation
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
Course of plasma tryptophan level and levels of tryptophan metabolites under standard low-flux hemodialysis.
Time frame: does not apply
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 14 Jul 2009.
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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.
Petra Reinke, Md PhD principal investigator
Charite University Medicine
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 Charite University, Berlin, Germany at 1 site in Germany.
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: finished, as of the sponsor's last update on 14 Jul 2009. 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 Germany. 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?
Course of plasma tryptophan level and levels of tryptophan metabolites under standard low-flux hemodialysis. (time frame: does not apply). 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 14 Jul 2009.