Completed

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

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What is being tested

Kidney Transplantation from alive relative donor

Procedure
Who is being recruted

Urogenital Diseases+10

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 60 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: May 2011
See protocol details

Summary

Principal SponsorNazarbayev University
Last updated: February 11, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2011

Actual date on which the first participant was enrolled.

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.

Principal SponsorNazarbayev University
Last updated: February 11, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesKidney Failure, Chronic

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Kidney transplantation from alive relative donor.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Republican Scientific Center for Emergency Medicine

Astana, KazakhstanOpen Republican Scientific Center for Emergency Medicine in Google Maps
CompletedOne Study Center