Functional Reserve Estimation of Donor Kidney

NCT01689272 | Completed Phase 4 DMC

• 1 other identifier: 0111RK00337
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Renal Disease

Keywords

Kidney transplantation,functional status,survival.

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Clinical and Laboratory,Imaging Parameters

  From 2 hours to 7 days

Other Outcomes (1)

• Pre-Operative Patients Health Status: Donor and Recipient

  For 1 week

Study Arms (1)

Kidney transplantation

EXPERIMENTAL

Kidney transplantation from alive relative donor.

Procedure: Kidney Transplantation from alive relative donor

Interventions

Kidney Transplantation from alive relative donor PROCEDURE

Donor kidney sampling, preservation, transport and transplantation

Kidney transplantation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nazarbayev University: lead

Study Sites (1)

Republican Scientific Center for Emergency Medicine

Astana, 010000, Kazakhstan

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gani M Kuttymuratov, Phd

  Advisor to the Board Chairman

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 21, 2012
• Study Start: May 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2013
• Last Updated: February 11, 2015

Record last verified: 2015-02

Locations

KA (1)