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Functional Reserve Estimation of Donor Kidney

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01689272
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : February 11, 2015
Information provided by (Responsible Party):
Nazarbayev University Medical Center

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.

Condition or disease Intervention/treatment Phase
End-stage Renal Disease Procedure: Kidney Transplantation from alive relative donor Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving of Morphological,Clinical Biochemical and Instrumental Functional Reserve Estimation of Donor Kidney
Study Start Date : May 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Kidney transplantation
Kidney transplantation from alive relative donor.
Procedure: Kidney Transplantation from alive relative donor
Donor kidney sampling, preservation, transport and transplantation

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Clinical and Laboratory,Imaging Parameters [ Time Frame: From 2 hours to 7 days ]
    • 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).

Other Outcome Measures:
  1. Pre-Operative Patients Health Status: Donor and Recipient [ Time Frame: For 1 week ]
    • Patient-donor health status.
    • Concomitant somatic pathology of a patient-recipient.
    • Time for Kidney transplantation.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01689272

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Republican Scientific Center for Emergency Medicine
Astana, Kazakhstan, 010000
Sponsors and Collaborators
Nazarbayev University Medical Center
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Principal Investigator: Gani M Kuttymuratov, Phd Advisor to the Board Chairman

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Responsible Party: Nazarbayev University Medical Center Identifier: NCT01689272     History of Changes
Other Study ID Numbers: 0111RK00337
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: February 11, 2015
Last Verified: February 2015

Keywords provided by Nazarbayev University Medical Center:
Kidney transplantation,functional status,survival.

Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases