Clinical trial NCT01689272: Functional Reserve Estimation of Donor Kidney
Official title: Improving of Morphological,Clinical Biochemical and Instrumental Functional Reserve Estimation of Donor Kidney
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End-stage Renal Disease
Keywords: Kidney transplantation,functional status,survival.
Lead sponsor: Nazarbayev University
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Functional Reserve Estimation of Donor Kidney
timeFrame: for 12 months
Secondary outcomes:
measure: Clinical and Laboratory,Imaging Parameters
timeFrame: From 2 hours to 7 days
Other outcomes:
measure: Pre-Operative Patients Health Status: Donor and Recipient
timeFrame: For 1 week
Locations:
city: Astana
country: Kazakhstan
facility: Republican Scientific Center for Emergency Medicine
Study officials:
affiliation: Advisor to the Board Chairman
name: Gani M Kuttymuratov, Phd
role: PRINCIPAL_INVESTIGATOR
References: