Chronic Renal FailureNCT00565994
A Study of Cytokine and Inflammatory Markers in Patients With Chronic Renal Failure
An observational study of Chronic Renal Failure, run by University of Oklahoma at 1 site in United States.
Trial summary
We hope to study components within the blood that may predict success, failure or other associated complications in relation to the type of vascular access being used. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- Blood Draw
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Sep 2010
- 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: Male and female patients of Dr. William Jennings and Dr. Pranay Kathuria undergoing dialysis therapy as outpatients. Dialysis and pre-dialysis patients will be recruited from Dr. Pranay Kathuria's practice. Normal volunteers will be recruited from family members of the pre-dialysis patients, Internal Medicine patients already scheduled to have blood drawn for other reasons, or from faculty/staff/student volunteers who are not otherwise involved with the study and are not in a subordinate role to any of the study investigators.
Who may be able to join
- Male and female patients of Dr. William Jennings and Dr. Pranay Kathuria undergoing dialysis therapy as outpatients
- Male and female patients of Dr. Pranay Kathuria who have been diagnosed with Stage 3, 4, or 5 chronic kidney disease, but who are not yet on dialysis.
- Healthy volunteers with no kidney disease, autoimmune disorders, recent (<6 months) chemotherapy treatment or corticosteroid use, or other chronic condition determined by the investigator to interfere with cytokine and inflammatory markers.
- 18 to 90 years of age
Who cannot join
- under 18 years of age
- over 90 years of age
- prisoners
- institutionalized patients
- pregnant individuals
- patients with mental illness who are not able to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Cytokine and Inflammatory Markers in Patients With Chronic Renal Failure According to Their Method of Vascular Access
We hope to study components within the blood that may predict success, failure or other associated complications in relation to the type of vascular access being used.
Read the detailed description
Renal failure affects more than 350,000 patients in the United States. All patients undergoing dialysis must have access to the vascular system (blood stream) for hemodialysis treatment. Methods of access include a catheter, or tube, that goes through the skin and into a large vein, a surgically created connection of a vein to an artery called an AV fistula, or a surgically created connection of a vein to artery using a graft or plastic tube. Previous research has shown considerable differences in the function and success in these types of vascular access for dialysis. Research investigators try to explain these differences and find the causes and explanations for the variations seen in vascular access.
Forty patients undergoing dialysis treatment will be evaluated by analyzing serum specimens obtained during outpatient hemodialysis access. Serum will also be collected from ten pre-dialysis patients and ten normal volunteers for comparison. Pre-dialysis patients are those who have Stage 3, 4, or 5 chronic kidney disease but are not yet on dialysis and have never had any type of created vascular access. Normal subjects will have no kidney disease, autoimmune disorders, recent (<6 months) chemotherapy treatment or corticosteroid use, or other chronic condition determined by the investigator to interfere with cytokine and inflammatory markers. The serum specimens will be analyzed for cytokine/inflammatory markers and correlated with clinical access type and other medical data and demographic information.
- Conditions
- Chronic Renal Failure
- Being tested
- Blood Draw
- Keywords
- hemodialysis, Vascular access, arteriovenous fistula, indwelling percutaneous catheters, arteriovenous grafts
- Medical subject headings
- Kidney Failure, Chronic, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawProcedure or surgery
For patients undergoing routine hemodialysis for chronic renal failure, 5-10 ml of blood will be removed from the dialysis tubing during vascular access. All other subjects will have 5-10 ml of blood drawn by routine venipuncture.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis patients | Male and female patients undergoing hemodialysis therapy as outpatients Receives: Procedure: Blood Draw | |
| Control | Male and female healthy volunteers Receives: Procedure: Blood Draw | |
| Pre-dialysis patients | Male and female patients with Stage 3, 4, or 5 chronic kidney disease, but not yet on dialysis Receives: Procedure: Blood Draw |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startJan 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Investigators
- William C Jennings, MD, Principal investigator, University of Oklahoma-Tulsa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565994
- Sponsor's protocol ID
- OUHSC IRB #13137
- Status last verified
- Sep 2010
- First submitted
- 29 Nov 2007
- Last updated
- 28 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Cytokine and Inflammatory Markers in Patients With Chronic Renal Failure According to Their Method of Vascular Access
- ClinicalTrials.gov ID
- NCT00565994
- Acronym / sponsor ID
- OUHSC IRB #13137
- Conditions
- Chronic Renal Failure
- Keywords
- hemodialysis, Vascular access, arteriovenous fistula, indwelling percutaneous catheters, arteriovenous grafts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 30 Nov 2007 (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.
We hope to study components within the blood that may predict success, failure or other associated complications in relation to the type of vascular access being used.
Detailed description
Renal failure affects more than 350,000 patients in the United States. All patients undergoing dialysis must have access to the vascular system (blood stream) for hemodialysis treatment. Methods of access include a catheter, or tube, that goes through the skin and into a large vein, a surgically created connection of a vein to an artery called an AV fistula, or a surgically created connection of a vein to artery using a graft or plastic tube. Previous research has shown considerable differences in the function and success in these types of vascular access for dialysis. Research investigators try to explain these differences and find the causes and explanations for the variations seen in vascular access.
Forty patients undergoing dialysis treatment will be evaluated by analyzing serum specimens obtained during outpatient hemodialysis access. Serum will also be collected from ten pre-dialysis patients and ten normal volunteers for comparison. Pre-dialysis patients are those who have Stage 3, 4, or 5 chronic kidney disease but are not yet on dialysis and have never had any type of created vascular access. Normal subjects will have no kidney disease, autoimmune disorders, recent (<6 months) chemotherapy treatment or corticosteroid use, or other chronic condition determined by the investigator to interfere with cytokine and inflammatory markers. The serum specimens will be analyzed for cytokine/inflammatory markers and correlated with clinical access type and other medical data and demographic information.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis patients | – | Procedure: Blood DrawMale and female patients undergoing hemodialysis therapy as outpatients |
| Control | – | Procedure: Blood DrawMale and female healthy volunteers |
| Pre-dialysis patients | – | Procedure: Blood DrawMale and female patients with Stage 3, 4, or 5 chronic kidney disease, but not yet on dialysis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients of Dr. William Jennings and Dr. Pranay Kathuria undergoing dialysis therapy as outpatients. Dialysis and pre-dialysis patients will be recruited from Dr. Pranay Kathuria's practice. Normal volunteers will be recruited from family members of the pre-dialysis patients, Internal Medicine patients already scheduled to have blood drawn for other reasons, or from faculty/staff/student volunteers who are not otherwise involved with the study and are not in a subordinate role to any of the study investigators.
Key inclusion criteria (4 listed)
- Male and female patients of Dr. William Jennings and Dr. Pranay Kathuria undergoing dialysis therapy as outpatients
- Male and female patients of Dr. Pranay Kathuria who have been diagnosed with Stage 3, 4, or 5 chronic kidney disease, but who are not yet on dialysis.
- Healthy volunteers with no kidney disease, autoimmune disorders, recent (<6 months) chemotherapy treatment or corticosteroid use, or other chronic condition determined by the investigator to interfere with cytokine and inflammatory markers.
- 18 to 90 years of age
Key exclusion criteria (6 listed)
- under 18 years of age
- over 90 years of age
- prisoners
- institutionalized patients
- pregnant individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawFor patients undergoing routine hemodialysis for chronic renal failure, 5-10 ml of blood will be removed from the dialysis tubing during vascular access. All other subjects will have 5-10 ml of blood drawn by routine venipuncture. | Procedure or surgery | Control, Hemodialysis patients, Pre-dialysis patients |
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 28 Sep 2010.
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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.
William C Jennings, MD principal investigator
University of Oklahoma-Tulsa
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 Renal Failure, run by University of Oklahoma at 1 site in United States.
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 6 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 28 Sep 2010. 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 United States. 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?
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 28 Sep 2010.