Functional Reserve Estimation of Donor Kidney

End-stage Renal Disease Clinical Trial

Official title:

Improving of Morphological,Clinical Biochemical and Instrumental Functional Reserve Estimation of Donor Kidney

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01689272
• Other study ID #: 0111RK00337
• Status: Completed
• Phase: Phase 4
• First received: September 17, 2012
• Last updated: February 10, 2015
• Start date: May 2011
• Est. completion date: December 2013

Study information

• Verified date: February 2015
• Source: Republican Scientific Center for Emergency Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kazakhstan: Ethical CommissionKazakhstan: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

Procedure:
• Kidney Transplantation from alive relative donor
Donor kidney sampling, preservation, transport and transplantation

Locations

Country	Name	City	State
Kazakhstan	Republican Scientific Center for Emergency Medicine	Astana

Sponsors (1)

Lead Sponsor	Collaborator
Republican Scientific Center for Emergency Medicine

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pre-Operative Patients Health Status: Donor and Recipient	Patient-donor health status.; Concomitant somatic pathology of a patient-recipient.; Time for Kidney transplantation.	For 1 week	Yes
Primary	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.	for 12 months	Yes
Secondary	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).	From 2 hours to 7 days	Yes