- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01689272
Functional Reserve Estimation of Donor Kidney
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Astana, Kazakhstan, 010000
- Republican Scientific Center for Emergency Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Kidney transplantation
Kidney transplantation from alive relative donor.
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Donor kidney sampling, preservation, transport and transplantation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Reserve Estimation of Donor Kidney
Time Frame: for 12 months
|
Graft survival is assessed on the following criteria:
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for 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical and Laboratory,Imaging Parameters
Time Frame: From 2 hours to 7 days
|
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From 2 hours to 7 days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre-Operative Patients Health Status: Donor and Recipient
Time Frame: For 1 week
|
|
For 1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gani M Kuttymuratov, Phd, Advisor to the Board Chairman
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0111RK00337
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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