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Functional Reserve Estimation of Donor Kidney

Primary Purpose

End-stage Renal Disease

Status
Completed
Phase
Phase 4
Locations
Kazakhstan
Study Type
Interventional
Intervention
Kidney Transplantation from alive relative donor
Sponsored by
Nazarbayev University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Renal Disease focused on measuring Kidney transplantation,functional status,survival.

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Republican Scientific Center for Emergency Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Kidney transplantation

Arm Description

Kidney transplantation from alive relative donor.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
September 17, 2012
Last Updated
February 10, 2015
Sponsor
Nazarbayev University
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1. Study Identification

Unique Protocol Identification Number
NCT01689272
Brief Title
Functional Reserve Estimation of Donor Kidney
Official Title
Improving of Morphological,Clinical Biochemical and Instrumental Functional Reserve Estimation of Donor Kidney
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nazarbayev University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease
Keywords
Kidney transplantation,functional status,survival.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kidney transplantation
Arm Type
Experimental
Arm Description
Kidney transplantation from alive relative donor.
Intervention Type
Procedure
Intervention Name(s)
Kidney Transplantation from alive relative donor
Intervention Description
Donor kidney sampling, preservation, transport and transplantation
Primary Outcome Measure Information:
Title
Functional Reserve Estimation of Donor Kidney
Description
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.
Time Frame
for 12 months
Secondary Outcome Measure Information:
Title
Clinical and Laboratory,Imaging Parameters
Description
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).
Time Frame
From 2 hours to 7 days
Other Pre-specified Outcome Measures:
Title
Pre-Operative Patients Health Status: Donor and Recipient
Description
Patient-donor health status. Concomitant somatic pathology of a patient-recipient. Time for Kidney transplantation.
Time Frame
For 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gani M Kuttymuratov, Phd
Organizational Affiliation
Advisor to the Board Chairman
Official's Role
Principal Investigator
Facility Information:
Facility Name
Republican Scientific Center for Emergency Medicine
City
Astana
ZIP/Postal Code
010000
Country
Kazakhstan

12. IPD Sharing Statement

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