Renal TransplantationNCT03338140
Outcome of Living Donor Renal Transplantation in Assiut Urology and Nephrology University Hospital ,Initial Experience
An observational study of Renal Transplantation, run by Assiut University at 1 site in Egypt.
Trial summary
evaluation of outcome of living donor renal transplantation in assiut urology and nephrology university Hospital regarding the survival of patients and grafts , complications and quality of life after transplantation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Transplantation
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2017to 1 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: -All recipients of renal transplantation in Assiut urology and nephrology university Hospital
Who may be able to join
- All recipients of renal transplantation in Assiut urology and nephrology university Hospital
Who cannot join
- All recipients of renal transplantation who were transplanted outside Assiut urology and nephrology university Hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assistant Lecturer of Urology in Assiut University
evaluation of outcome of living donor renal transplantation in assiut urology and nephrology university Hospital regarding the survival of patients and grafts , complications and quality of life after transplantation.
Read the detailed description
Renal failure is a widespread life threatening problem affecting a variety of age groups that needs a replacement therapy either regular dialysis with its drawbacks or kidney transplantation. Kidney transplantation is the treatment of choice for suitable candidates with ESRD. Since the advent of kidney transplantation in 1954, allograft and patient survival in the world have markedly improved because of advances in surgical techniques and immunosuppression. Few studies have compared kidney transplant outcomes In different countries. Because of varying allocation policies, cultural differences influencing preferences for living vs deceased donation, and government-funded health care in some countries, it is possible that post transplant outcomes are vastly different in other countries. Many studies described the current status of kidney allograft and patient survival in different countries based on data from the 2014 Scientific Registry of Transplant Recipients (SRTR) Annual Data Report. These outcomes are compared with those from Australia and New Zealand (ANZ), Europe, and Canada, using the most recent published registry data. A study was conducted showing that a total of 17,814 adult kidney transplants were performed in the United States in 2014. Of these, 12,279 were from deceased donors and 5535 were from living donors. Deceased donor allograft survival rates have improved over time. The most recent SRTR annual report showed long-term outcome data on recipients who underwent transplant from 1991 to 2014. From 2010 to 2014, the unadjusted 1-year allograft survival rate for recipients of a first deceased donor kidney transplant was 93.4% . For second or subsequent deceased donor transplants, the 1- year unadjusted allograft survival rate was comparable at 92.5%. It is well established that living donor kidney transplants are associated with superior post-transplant outcomes compared with deceased donor transplants, and this was reflected in the SRTR data. In recipients undergoing a primary living donor kidney transplant, the 1-year unadjusted allograft survival rate was 97.2%. In those undergoing retransplant from a living donor (first transplant from deceased or living donor), 1-year allograft survival was similar at 97.3%. Five-year unadjusted allograft survival rates for a first living donor kidney transplant and a second or subsequent transplant were 84.6% and 81.4%, respectively. Despite better outcomes, numbers of living donor transplants in the United States have decreased over the past 10 years; the largest decrease was in living-related donor kidney transplants, from 4340 in 2004 to 2693 in 2014.This underscores the ongoing need to encourage and support living donation. Potential explanations for the decline in living kidney donation include an aging U.S.A population such that potential donors are older, often have more comorbidity, and may not be medically suitable, financial disincentives, changes in organ allocation and donor selection criteria, and inadequate public awareness about the benefits of living organ donation.Although the recipient's health insurance covers the donor's donation related medical expenses, it does not reimburse for other expenses (eg, travel to the transplant center for predonation testing and surgery, lodging, lost wages during the post-surgery recovery period, especially for selfemployed or part-time workers, and higher premiums for health or life insurance or, difficulty obtaining it, after donation).The average out-of-pocket cost incurred by patients after living donation is reported to be $5000. In June 2014, the transplant community convened a Consensus Conference on Best Practices in Live Kidney Donation and issued several recommendations with the goal of making living donation financially neutral. Progress is being made as the Living Donor Protection Act was introduced in Congress in February 2016. A study showed that Patient Survival Recipients of living donor kidney transplants enjoy high survival rates, with little difference in outcomes for primary transplant and retransplant. The unadjusted 1-year patient survival rate was 97.0% for primary deceased donor transplant recipients from 2010 to 2014 and 97.2% for retransplant recipients. Patient survival at 5 years was 86.1% for first-transplant recipients and 88.9% for retransplant recipients who underwent deceased donor transplant from 2005 to 2009. For living donor transplant recipients, patient survival at 1 year and 5 years was 98.7% and 93.1% (primary transplant) and 99.0% and 92.9% (retransplant), respectively. This likely reflects selection bias during the evaluation for retransplant, when patients who were non adherent (perhaps leading to allograft failure) or who have substantial comorbidity are usually not deemed candidates for retransplant. Kidney transplant before dialysis initiation is associated with better post-transplant outcomes than transplant after dialysis initiation. another study reported that less than 6 months of pretransplant dialysis was associated with a 17% higher risk of death-censored allograft loss compared with preemptive transplant. The risk of allograft loss increased with longer pre -transplant dialysis time, although the relative increase after 3 years of dialysis was minimal. Similarly, this study showed that 6 months or longer of dialysis pretransplant was linked to a higher risk of death post-transplant compared with preemptive transplant. Other advantages of preemptive transplant include lower rates of delayed graft function and lower overall ESRD treatment costs compared with maintenance dialysis. In 2014, 17.1% of U.S.A adult transplant recipients underwent a pre emptive transplant. Although the proportion of preemptive living donor transplants increased from 23% in 1995 to 32% in 2014, growth has been stagnant since 2004 despite recognition of the benefits and new paradigms, such as the Kidney First Initiative. Previously, deceased donor kidneys were classified as standard criteria donor (SCD) or expanded criteria donor (ECD). A study showed that U.S.A has the highest 1-year survival rate for both primary and retransplant cases as compared to Australia ,Canada and Europe .while Australia has the highest 5-year survival rates .Canada and Europe have the lowest survival rates.
this study will be conducted on all recipient of living donor kidney transplantation in Assiut university urology \&nephrology hospital to detect the outcome regarding survival rates of both grafts \& patients, post-transplant quality of life and incidence of post -transplant complications.
Survival may be short term meaning that the graft will be functioning only for the 1st year while long term survival for more than 1st year, at any time if the patient returns to regular dialysis this means failure of the graft. Quality of life will be evaluated regarding physical performance, appearance, anxiety , frustration, depression and burden of immunosuppressants , comparison between post-transplant and pre- transplant status.
Complications of renal transplantation may be surgical or non surgical . Surgical complications may be urinary as (urinary leakage,urinary obstruction, urinoma ),lymphatic (lymphocele,lymphatic leakage and lymphatic obstruction)and vascular as ( renal artery stenosis , renal vein thrombosis,vascular aneurysms and rejection) . Non surgical as ( rejection, side effects of Immunosuppressants as viral infections,nephrotoxicity,skin changes,malignancy,etc) .
- Conditions
- Renal Transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of quality of life after renal transplantation
Evaluation of physical and physological performance changes pre and post transplantation using kidney disease quality of life(KDQOL) score
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start1 Nov 2017
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mostafa Abdel Gawad, Assiut University
- Investigators
- Nasreldin Abdelall, Lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338140
- Sponsor's protocol ID
- Renal transplantation
- Status last verified
- Oct 2017
- First submitted
- 23 Oct 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rodrigue JR, Schold JD, Mandelbrot DA. The decline in living kidney donation in the United States: random variation or cause for concern? Transplantation. 2013 Nov 15;96(9):767-73. doi: 10.1097/TP.0b013e318298fa61.
PubMed 23759882Tushla L, Rudow DL, Milton J, Rodrigue JR, Schold JD, Hays R; American Society of Transplantation. Living-Donor Kidney Transplantation: Reducing Financial Barriers to Live Kidney Donation--Recommendations from a Consensus Conference. Clin J Am Soc Nephrol. 2015 Sep 4;10(9):1696-702. doi: 10.2215/CJN.01000115. Epub 2015 May 22.
PubMed 26002904Clarke KS, Klarenbach S, Vlaicu S, Yang RC, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. The direct and indirect economic costs incurred by living kidney donors-a systematic review. Nephrol Dial Transplant. 2006 Jul;21(7):1952-60. doi: 10.1093/ndt/gfl069. Epub 2006 Mar 22.
PubMed 16554329Meier-Kriesche HU, Port FK, Ojo AO, Rudich SM, Hanson JA, Cibrik DM, Leichtman AB, Kaplan B. Effect of waiting time on renal transplant outcome. Kidney Int. 2000 Sep;58(3):1311-7. doi: 10.1046/j.1523-1755.2000.00287.x.
PubMed 10972695Kasiske BL, Snyder JJ, Matas AJ, Ellison MD, Gill JS, Kausz AT. Preemptive kidney transplantation: the advantage and the advantaged. J Am Soc Nephrol. 2002 May;13(5):1358-64. doi: 10.1097/01.asn.0000013295.11876.c9.
PubMed 11961024Friedewald JJ, Reese PP. The kidney-first initiative: what is the current status of preemptive transplantation? Adv Chronic Kidney Dis. 2012 Jul;19(4):252-6. doi: 10.1053/j.ackd.2012.05.001.
PubMed 22732045Rao PS, Ojo A. The alphabet soup of kidney transplantation: SCD, DCD, ECD--fundamentals for the practicing nephrologist. Clin J Am Soc Nephrol. 2009 Nov;4(11):1827-31. doi: 10.2215/CJN.02270409. Epub 2009 Sep 24.
PubMed 19808229
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistant Lecturer of Urology in Assiut University
- ClinicalTrials.gov ID
- NCT03338140
- Acronym / sponsor ID
- Renal transplantation
- Conditions
- Renal Transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 9 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
evaluation of outcome of living donor renal transplantation in assiut urology and nephrology university Hospital regarding the survival of patients and grafts , complications and quality of life after transplantation.
Detailed description
Renal failure is a widespread life threatening problem affecting a variety of age groups that needs a replacement therapy either regular dialysis with its drawbacks or kidney transplantation. Kidney transplantation is the treatment of choice for suitable candidates with ESRD. Since the advent of kidney transplantation in 1954, allograft and patient survival in the world have markedly improved because of advances in surgical techniques and immunosuppression. Few studies have compared kidney transplant outcomes In different countries. Because of varying allocation policies, cultural differences influencing preferences for living vs deceased donation, and government-funded health care in some countries, it is possible that post transplant outcomes are vastly different in other countries. Many studies described the current status of kidney allograft and patient survival in different countries based on data from the 2014 Scientific Registry of Transplant Recipients (SRTR) Annual Data Report. These outcomes are compared with those from Australia and New Zealand (ANZ), Europe, and Canada, using the most recent published registry data. A study was conducted showing that a total of 17,814 adult kidney transplants were performed in the United States in 2014. Of these, 12,279 were from deceased donors and 5535 were from living donors. Deceased donor allograft survival rates have improved over time. The most recent SRTR annual report showed long-term outcome data on recipients who underwent transplant from 1991 to 2014. From 2010 to 2014, the unadjusted 1-year allograft survival rate for recipients of a first deceased donor kidney transplant was 93.4% . For second or subsequent deceased donor transplants, the 1- year unadjusted allograft survival rate was comparable at 92.5%. It is well established that living donor kidney transplants are associated with superior post-transplant outcomes compared with deceased donor transplants, and this was reflected in the SRTR data. In recipients undergoing a primary living donor kidney transplant, the 1-year unadjusted allograft survival rate was 97.2%. In those undergoing retransplant from a living donor (first transplant from deceased or living donor), 1-year allograft survival was similar at 97.3%. Five-year unadjusted allograft survival rates for a first living donor kidney transplant and a second or subsequent transplant were 84.6% and 81.4%, respectively. Despite better outcomes, numbers of living donor transplants in the United States have decreased over the past 10 years; the largest decrease was in living-related donor kidney transplants, from 4340 in 2004 to 2693 in 2014.This underscores the ongoing need to encourage and support living donation. Potential explanations for the decline in living kidney donation include an aging U.S.A population such that potential donors are older, often have more comorbidity, and may not be medically suitable, financial disincentives, changes in organ allocation and donor selection criteria, and inadequate public awareness about the benefits of living organ donation.Although the recipient's health insurance covers the donor's donation related medical expenses, it does not reimburse for other expenses (eg, travel to the transplant center for predonation testing and surgery, lodging, lost wages during the post-surgery recovery period, especially for selfemployed or part-time workers, and higher premiums for health or life insurance or, difficulty obtaining it, after donation).The average out-of-pocket cost incurred by patients after living donation is reported to be $5000. In June 2014, the transplant community convened a Consensus Conference on Best Practices in Live Kidney Donation and issued several recommendations with the goal of making living donation financially neutral. Progress is being made as the Living Donor Protection Act was introduced in Congress in February 2016. A study showed that Patient Survival Recipients of living donor kidney transplants enjoy high survival rates, with little difference in outcomes for primary transplant and retransplant. The unadjusted 1-year patient survival rate was 97.0% for primary deceased donor transplant recipients from 2010 to 2014 and 97.2% for retransplant recipients. Patient survival at 5 years was 86.1% for first-transplant recipients and 88.9% for retransplant recipients who underwent deceased donor transplant from 2005 to 2009. For living donor transplant recipients, patient survival at 1 year and 5 years was 98.7% and 93.1% (primary transplant) and 99.0% and 92.9% (retransplant), respectively. This likely reflects selection bias during the evaluation for retransplant, when patients who were non adherent (perhaps leading to allograft failure) or who have substantial comorbidity are usually not deemed candidates for retransplant. Kidney transplant before dialysis initiation is associated with better post-transplant outcomes than transplant after dialysis initiation. another study reported that less than 6 months of pretransplant dialysis was associated with a 17% higher risk of death-censored allograft loss compared with preemptive transplant. The risk of allograft loss increased with longer pre -transplant dialysis time, although the relative increase after 3 years of dialysis was minimal. Similarly, this study showed that 6 months or longer of dialysis pretransplant was linked to a higher risk of death post-transplant compared with preemptive transplant. Other advantages of preemptive transplant include lower rates of delayed graft function and lower overall ESRD treatment costs compared with maintenance dialysis. In 2014, 17.1% of U.S.A adult transplant recipients underwent a pre emptive transplant. Although the proportion of preemptive living donor transplants increased from 23% in 1995 to 32% in 2014, growth has been stagnant since 2004 despite recognition of the benefits and new paradigms, such as the Kidney First Initiative. Previously, deceased donor kidneys were classified as standard criteria donor (SCD) or expanded criteria donor (ECD). A study showed that U.S.A has the highest 1-year survival rate for both primary and retransplant cases as compared to Australia ,Canada and Europe .while Australia has the highest 5-year survival rates .Canada and Europe have the lowest survival rates.
this study will be conducted on all recipient of living donor kidney transplantation in Assiut university urology \&nephrology hospital to detect the outcome regarding survival rates of both grafts \& patients, post-transplant quality of life and incidence of post -transplant complications.
Survival may be short term meaning that the graft will be functioning only for the 1st year while long term survival for more than 1st year, at any time if the patient returns to regular dialysis this means failure of the graft. Quality of life will be evaluated regarding physical performance, appearance, anxiety , frustration, depression and burden of immunosuppressants , comparison between post-transplant and pre- transplant status.
Complications of renal transplantation may be surgical or non surgical . Surgical complications may be urinary as (urinary leakage,urinary obstruction, urinoma ),lymphatic (lymphocele,lymphatic leakage and lymphatic obstruction)and vascular as ( renal artery stenosis , renal vein thrombosis,vascular aneurysms and rejection) . Non surgical as ( rejection, side effects of Immunosuppressants as viral infections,nephrotoxicity,skin changes,malignancy,etc) .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- -All recipients of renal transplantation in Assiut urology and nephrology university Hospital
Key inclusion criteria (1 listed)
- All recipients of renal transplantation in Assiut urology and nephrology university Hospital
Key exclusion criteria (1 listed)
- All recipients of renal transplantation who were transplanted outside Assiut urology and nephrology university Hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of quality of life after renal transplantation
Time frame: 2 years
Evaluation of physical and physological performance changes pre and post transplantation using kidney disease quality of life(KDQOL) score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Background: PubMed 23759882Rodrigue JR, Schold JD, Mandelbrot DA. The decline in living kidney donation in the United States: random variation or cause for concern? Transplantation. 2013 Nov 15;96(9):767-73. doi: 10.1097/TP.0b013e318298fa61.
- Background: PubMed 26002904Tushla L, Rudow DL, Milton J, Rodrigue JR, Schold JD, Hays R; American Society of Transplantation. Living-Donor Kidney Transplantation: Reducing Financial Barriers to Live Kidney Donation--Recommendations from a Consensus Conference. Clin J Am Soc Nephrol. 2015 Sep 4;10(9):1696-702. doi: 10.2215/CJN.01000115. Epub 2015 May 22.
- Background: PubMed 16554329Clarke KS, Klarenbach S, Vlaicu S, Yang RC, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. The direct and indirect economic costs incurred by living kidney donors-a systematic review. Nephrol Dial Transplant. 2006 Jul;21(7):1952-60. doi: 10.1093/ndt/gfl069. Epub 2006 Mar 22.
- Background: PubMed 10972695Meier-Kriesche HU, Port FK, Ojo AO, Rudich SM, Hanson JA, Cibrik DM, Leichtman AB, Kaplan B. Effect of waiting time on renal transplant outcome. Kidney Int. 2000 Sep;58(3):1311-7. doi: 10.1046/j.1523-1755.2000.00287.x.
- Background: PubMed 11961024Kasiske BL, Snyder JJ, Matas AJ, Ellison MD, Gill JS, Kausz AT. Preemptive kidney transplantation: the advantage and the advantaged. J Am Soc Nephrol. 2002 May;13(5):1358-64. doi: 10.1097/01.asn.0000013295.11876.c9.
- Background: PubMed 22732045Friedewald JJ, Reese PP. The kidney-first initiative: what is the current status of preemptive transplantation? Adv Chronic Kidney Dis. 2012 Jul;19(4):252-6. doi: 10.1053/j.ackd.2012.05.001.
- Background: PubMed 19808229Rao PS, Ojo A. The alphabet soup of kidney transplantation: SCD, DCD, ECD--fundamentals for the practicing nephrologist. Clin J Am Soc Nephrol. 2009 Nov;4(11):1827-31. doi: 10.2215/CJN.02270409. Epub 2009 Sep 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasreldin Abdelall, Lecturer principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplantation, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of quality of life after renal transplantation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03338140, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.