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Functional Reserve Estimation of Donor Kidney

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01689272
Enrollment
60
Registered
2012-09-21
Start date
2011-05-31
Completion date
2013-12-31
Last updated
2015-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage Renal Disease

Keywords

Kidney transplantation,functional status,survival.

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.

Interventions

PROCEDUREKidney Transplantation from alive relative donor

Donor kidney sampling, preservation, transport and transplantation

Sponsors

Nazarbayev University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Functional Reserve Estimation of Donor Kidneyfor 12 monthsGraft 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

MeasureTime frameDescription
Clinical and Laboratory,Imaging ParametersFrom 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).

Other

MeasureTime frameDescription
Pre-Operative Patients Health Status: Donor and RecipientFor 1 week* Patient-donor health status. * Concomitant somatic pathology of a patient-recipient. * Time for Kidney transplantation.

Countries

Kazakhstan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026