Kidney TransplantationNCT00204178
The Role of Reactive Oxygen Species in Ischaemia-Reperfusion Injury of the Transplanted Kidney
An observational study of Kidney Transplantation, run by Uniwersytet Mikolaja Kopernika w Toruniu at 1 site in Poland.
Trial summary
Measurement of reactive oxygen species production and antioxidant system status before and directly after reperfusion of the transplanted kidney and influence of oxidant stress on kidney function in 2 and 6 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Oxidative stress in kidney transplant recipients
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- Apr 2003to Sep 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- consecutive patients accepted for and undergoing cadaveric kidney transplantation
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
Poland1 site
Klinika Transplantologii, Szpital Uniwersytecki, ul. M. Sklodowskiej-Curie 9
Bydgoszcz, 85-094
About this study
Measurement of reactive oxygen species production and antioxidant system status before and directly after reperfusion of the transplanted kidney and influence of oxidant stress on kidney function in 2 and 6 weeks.
Read the detailed description
Oxidative stress is one of the most important factors in ischaemia-reperfusion injury to the transplanted organ. In kidney transplant recipients following factors were measured: glutathione level, activities of glutathione peroxidase (GSH-PX), catalase (CAT) and superoxide dismutase (SOD) and superoxide anion production by granulocytes in whole blood without and after the stimulation with zymosan.
Blood was sampled from peripheral vein (before reperfusion) and directly from renal vein (5 and 15 minutes after reperfusion).
Transplanted kidney function was evaluated by the incidence and length of Delayed Graft Function and serum creatinine level in 2 and 6 weeks after transplantation.
- Conditions
- Kidney Transplantation
- Being tested
- Oxidative stress in kidney transplant recipients
- Keywords
- Kidney transplantation, Reperfusion injury
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxidative stress in kidney transplant recipientsBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2003
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies 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
- Defined population
- Time perspective
- Other
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Uniwersytet Mikolaja Kopernika w Toruniu
- Sponsor type
- University, hospital or other
- Investigators
- Zbigniew Wlodarczyk, MD,PhD, Study director, Klinika Transplantologii Collegium Medicum UMK w Toruniu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204178
- Sponsor's protocol ID
- KB/38/2003
- Status last verified
- Aug 2005
- First submitted
- 13 Sep 2005
- Last updated
- 1 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Reactive Oxygen Species in Ischaemia-Reperfusion Injury of the Transplanted Kidney
- ClinicalTrials.gov ID
- NCT00204178
- Acronym / sponsor ID
- KB/38/2003
- Conditions
- Kidney Transplantation
- Keywords
- Kidney transplantation, Reperfusion injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Uniwersytet Mikolaja Kopernika w ToruniuUniversity, hospital or other
- Study start
- Apr 2003
- Study completion
- Sep 2005
- First posted
- 20 Sep 2005 (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.
Measurement of reactive oxygen species production and antioxidant system status before and directly after reperfusion of the transplanted kidney and influence of oxidant stress on kidney function in 2 and 6 weeks.
Detailed description
Oxidative stress is one of the most important factors in ischaemia-reperfusion injury to the transplanted organ. In kidney transplant recipients following factors were measured: glutathione level, activities of glutathione peroxidase (GSH-PX), catalase (CAT) and superoxide dismutase (SOD) and superoxide anion production by granulocytes in whole blood without and after the stimulation with zymosan.
Blood was sampled from peripheral vein (before reperfusion) and directly from renal vein (5 and 15 minutes after reperfusion).
Transplanted kidney function was evaluated by the incidence and length of Delayed Graft Function and serum creatinine level in 2 and 6 weeks after transplantation.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- consecutive patients accepted for and undergoing cadaveric kidney transplantation
Key exclusion criteria (1 listed)
- no informed consent
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 |
|---|---|---|
| Oxidative stress in kidney transplant recipients | Behavioural | – |
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 1 Dec 2005.
Related trials for Kidney Transplantation
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
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.
Zbigniew Wlodarczyk, MD,PhD study director
Klinika Transplantologii Collegium Medicum UMK w Toruniu
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 Kidney Transplantation, run by Uniwersytet Mikolaja Kopernika w Toruniu at 1 site in Poland.
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 1 Dec 2005. 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 Poland. 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?
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 1 Dec 2005.