Functional Reserve Estimation of Donor Kidney

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Republican Scientific Center for Emergency Medicine
Sponsor:
Information provided by (Responsible Party):
Republican Scientific Center for Emergency Medicine
ClinicalTrials.gov Identifier:
NCT01689272
First received: September 17, 2012
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
End-stage Renal Disease
Procedure: Kidney Transplantation from alive relative donor
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving of Morphological,Clinical Biochemical and Instrumental Functional Reserve Estimation of Donor Kidney

Resource links provided by NLM:


Further study details as provided by Republican Scientific Center for Emergency Medicine:

Primary Outcome Measures:
  • Functional Reserve Estimation of Donor Kidney [ Time Frame: for 12 months ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: From 2 hours to 7 days ] [ Designated as safety issue: Yes ]
    • 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:
  • Pre-Operative Patients Health Status: Donor and Recipient [ Time Frame: For 1 week ] [ Designated as safety issue: Yes ]
    • Patient-donor health status.
    • Concomitant somatic pathology of a patient-recipient.
    • Time for Kidney transplantation.


Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: October 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kidney transplantation
Kidney transplantation from alive relative donor.
Procedure: Kidney Transplantation from alive relative donor
Donor kidney sampling, preservation, transport and transplantation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01689272

Contacts
Contact: Gani M Kuttymuratov, Phd +77172702912 ext +77018812206 aiger2000@mail.ru
Contact: Kuat P Oshakbayev, Phd, Dsc +77172702905 ext +77013999394 okp.kuat@mail.ru

Locations
Kazakhstan
Republican Scientific Center for Emergency Medicine Recruiting
Astana, Kazakhstan, 010000
Contact: Gani M Kuttymuratov, Phd    +77172702912 ext +77018812206    aiger2000@mail.ru   
Contact: Kuat P Oshakbayev, Phd, Dsc    +77172702905 ext +77013999394    okp.kuat@mail.ru   
Principal Investigator: Gani M Kuttymuratov, Phd         
Sponsors and Collaborators
Republican Scientific Center for Emergency Medicine
Investigators
Principal Investigator: Gani M Kuttymuratov, Phd Advisor to the Board Chairman
  More Information

No publications provided

Responsible Party: Republican Scientific Center for Emergency Medicine
ClinicalTrials.gov Identifier: NCT01689272     History of Changes
Other Study ID Numbers: 0111RK00337
Study First Received: September 17, 2012
Last Updated: September 20, 2012
Health Authority: Kazakhstan: Ethical Commission
Kazakhstan: Ministry of Public Health

Keywords provided by Republican Scientific Center for Emergency Medicine:
Kidney transplantation,functional status,survival.

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

ClinicalTrials.gov processed this record on July 20, 2014