End-stage Renal DiseasePhase 4NCT01689272
Functional Reserve Estimation of Donor Kidney
A Phase 4 study testing Kidney Transplantation from alive relative donor in people with End-stage Renal Disease, run by Nazarbayev University at 1 site in Kazakhstan.
Trial summary
The purpose of the study: To estimate the role of morphological, clinical, biochemical and imaging studies at stages of kidney transplantation (medical therapy, explantation, preservation, transplantation). To improve the ways of preserving optimal functional parameters of renal transplants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Kidney Transplantation from alive relative donor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteKazakhstan
- Study dates
- May 2011to Dec 2013
- Phase
- Phase 4
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- recipients-patients with end-stage renal disease;
- donor healthy people without absolute contraindications to the kidney transplantation;
- donor and recipients who are both in the genetic and non-genetic related to each other.
- obligatory immunological compatibility by HLA-phenotyping provided that the donor and recipient are not relatives with each other;
- negative result of cross-match between donors and recipients;
- presence of pre-existing lymphotoxic antibodies in a recipient less than 50%;
- absence of standard absolute contraindications in a donor and in a recipient for surgeric intervention.
- Age is 18-60 years.
Who cannot join
- patients with absolute contraindications to surgery: diseases of organs and systems having a threating risk to the life of donor and recipient during and after surgery;
- immunological incompatibility between donor and recipient;
- high level of pre-existing lymphotoxic antibodies in a recipient more than 50%, uncorrected by Therapy;
- donor age is under 18 and over 60 years;
- incapable persons;
- absence of a notarized consent form to kidney transplantation;
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- presence of the active phase of viral infection with hepatitis B and C;
- positive results of blood tests for HIV/AIDS, syphilis;
- patients with severe concomitant pathology of kidneys, (or) heart and (or)liver.
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site
Republican Scientific Center for Emergency Medicine
Astana, 010000
About this study
Official title: Improving of Morphological,Clinical Biochemical and Instrumental Functional Reserve Estimation of Donor Kidney
The purpose of the study:
- To estimate the role of morphological, clinical, biochemical and imaging studies at stages of kidney transplantation (medical therapy, explantation, preservation, transplantation).
- To improve the ways of preserving optimal functional parameters of renal transplants.
Read the detailed description
Terminal chronic renal failure (ESRD) as a result of almost any chronic kidney disease develops due to progressive loss of nephrons. This state is characterized by a gradual deterioration of the functional abilities of not only the kidneys, but also the whole body. Currently, ESRD is among the first ten causes of mortality .
Transplantation of donor organs is the only radical treatment for various diseases of the terminal, for patients with a fatal prognosis.
Kidney transplantation has allowed not only save lives, but also to return to normal life, tens of thousands of people. Survival of renal transplant recipients is growing.
Despite the progress made in many clinics worldwide in recent years in the field of transplantation, kidney transplantation, does not settle the problem of reperfusion injury and the associated post-transplant dysfunction with the absence of clear indicators of morphological, clinical, biochemical and instrumental methods to assess functional reserve of organs that remain relevant and meaningful.
- Conditions
- End-stage Renal Disease
- Being tested
- Kidney Transplantation from alive relative donor
- Keywords
- Kidney transplantation,functional status,survival.
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney Transplantation from alive relative donorProcedure or surgery
Donor kidney sampling, preservation, transport and transplantation
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplantation | Experimental | Kidney transplantation from alive relative donor. Receives: Procedure: Kidney Transplantation from alive relative donor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Reserve Estimation of Donor Kidney
Graft survival is assessed on the following criteria:
- The duration of the functioning graft
- Clinical, laboratory and device functioning graft.
- Morphological and histological study of the stages of transplantation (for withdrawal, before implantation) and the post-transplant period (with the threat of rejection.) Study of the blood recipient: Laboratory tests of blood recipient: biochemical analysis, the composition of the electrolyte, acid-base status, the level of immunosuppressants. Immunological typing for HLA-system. Cross-typing of donor and recipient, the level of pre-existing limfotsitotoksicheskih antibodies in the recipient.Patients survival.
Measured: for 12 months
Secondary outcomes (1)
Clinical and Laboratory,Imaging Parameters
- Intraoperational Macroscopic Description of signs of kidney ischemia: turgor, colour, consistency of transplanted kidney, pulse characteristics of renal artery.
- Signs of graft rejection: increasing of temperature, blood pressure, the levels of waste products (blood creatinine, blood urea).
Measured: From 2 hours to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nazarbayev University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gani M Kuttymuratov, Phd, Principal investigator, Advisor to the Board Chairman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689272
- Sponsor's protocol ID
- 0111RK00337
- Status last verified
- Feb 2015
- First submitted
- 17 Sep 2012
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving of Morphological,Clinical Biochemical and Instrumental Functional Reserve Estimation of Donor Kidney
- ClinicalTrials.gov ID
- NCT01689272
- Acronym / sponsor ID
- 0111RK00337
- Conditions
- End-stage Renal Disease
- Keywords
- Kidney transplantation,functional status,survival.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nazarbayev UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Sep 2012 (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 purpose of the study:
- To estimate the role of morphological, clinical, biochemical and imaging studies at stages of kidney transplantation (medical therapy, explantation, preservation, transplantation).
- To improve the ways of preserving optimal functional parameters of renal transplants.
Detailed description
Terminal chronic renal failure (ESRD) as a result of almost any chronic kidney disease develops due to progressive loss of nephrons. This state is characterized by a gradual deterioration of the functional abilities of not only the kidneys, but also the whole body. Currently, ESRD is among the first ten causes of mortality .
Transplantation of donor organs is the only radical treatment for various diseases of the terminal, for patients with a fatal prognosis.
Kidney transplantation has allowed not only save lives, but also to return to normal life, tens of thousands of people. Survival of renal transplant recipients is growing.
Despite the progress made in many clinics worldwide in recent years in the field of transplantation, kidney transplantation, does not settle the problem of reperfusion injury and the associated post-transplant dysfunction with the absence of clear indicators of morphological, clinical, biochemical and instrumental methods to assess functional reserve of organs that remain relevant and meaningful.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney transplantation | Experimental | Procedure: Kidney Transplantation from alive relative donorKidney transplantation from alive relative donor. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- recipients-patients with end-stage renal disease;
- donor healthy people without absolute contraindications to the kidney transplantation;
- donor and recipients who are both in the genetic and non-genetic related to each other.
- obligatory immunological compatibility by HLA-phenotyping provided that the donor and recipient are not relatives with each other;
- negative result of cross-match between donors and recipients;
Key exclusion criteria (9 listed)
- patients with absolute contraindications to surgery: diseases of organs and systems having a threating risk to the life of donor and recipient during and after surgery;
- immunological incompatibility between donor and recipient;
- high level of pre-existing lymphotoxic antibodies in a recipient more than 50%, uncorrected by Therapy;
- donor age is under 18 and over 60 years;
- incapable persons;
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 |
|---|---|---|
| Kidney Transplantation from alive relative donorDonor kidney sampling, preservation, transport and transplantation | Procedure or surgery | Kidney transplantation |
Primary outcome
Functional Reserve Estimation of Donor Kidney
Time frame: for 12 months
Graft survival is assessed on the following criteria: * The duration of the functioning graft * Clinical, laboratory and device functioning graft. * Morphological and histological study of the stages of transplantation (for withdrawal, before implantation) and the post-transplant period (with the threat of rejection.) Study of the blood recipient: Laboratory tests of blood recipient: biochemical analysis, the composition of the electrolyte, acid-base status, the level of immunosuppressants. Immunological typing for HLA-system. Cross-typing of donor and recipient, the level of pre-existing limfotsitotoksicheskih antibodies in the recipient.Patients survival.
1 secondary outcome
Clinical and Laboratory,Imaging Parameters
Time frame: From 2 hours to 7 days
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 11 Feb 2015.
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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.
Gani M Kuttymuratov, Phd principal investigator
Advisor to the Board Chairman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Kidney Transplantation from alive relative donor in people with End-stage Renal Disease, run by Nazarbayev University at 1 site in Kazakhstan.
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 8 inclusion and 9 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 11 Feb 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 Kazakhstan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Functional Reserve Estimation of Donor Kidney (time frame: for 12 months). 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 11 Feb 2015.