Functional Reserve Estimation of Donor Kidney

Phase 4

Completed

• Conditions: End-stage Renal Disease
• Interventions: Procedure: Kidney Transplantation from alive relative donor

• Registration Number: NCT01689272
• Lead Sponsor: Nazarbayev University

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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2011-09
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-21
• Study Completion: 2013-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-10
• Last Update Posted: 2015-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Kidney transplantation	Kidney Transplantation from alive relative donor	Kidney transplantation from alive relative donor.

Primary Outcome Measures

Name	Time	Method
Functional Reserve Estimation of Donor Kidney	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

Name	Time	Method
Clinical and Laboratory,Imaging Parameters	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).

Trial Locations

Locations (1)

Republican Scientific Center for Emergency Medicine; 🇰🇿 Astana, Kazakhstan