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van CCT (UK)

van CCT (UK)

Lange termijn follow-up na levende nierdonatie.

- candidate number14227
- NTR NumberNTR3795
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jan-2013
- Secondary IDsNL42270.078.12 CCMO
- Public TitleLange termijn follow-up na levende nierdonatie.
- Scientific TitleLong-term follow-up after live kidney donation: A matched controlled study on renal function and quality of life.
- hypothesisThere is no difference in long-term follow-up between live kidney donors and the general population.
- Healt Condition(s) or Problem(s) studiedLive kidney donors, Follow-up, Kidney fuction, Quality of life
- Inclusion criteriaAll live kidney donors of Erasmus University Medical Center Rotterdam who donated their kidney between 1994 and 2010.
- Exclusion criteriaN/A
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-feb-2013
- planned closingdate1-mrt-2015
- Target number of participants975
- InterventionsN/A
- Primary outcomeKidney function (GFR).
- Secondary outcome1. Survival;
2. Incidence of hypertension;
3. Incidence of diabetes;
4. Bloodpressure;
5. Incidence of cardiovascular events;
6. Measurements of remaining kidney (ultrasound);
7. Quality of life (SF-36);
8. Proteinuria and microalbuminuria.
- Timepoints1. Baseline;
2. Follow-up.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Stichting Coolsingel
- PublicationsN/A
- Brief summaryLive kidney donation has been proven safe on the short-term. However, longitudinal studies regarding the long-term effects have been lacking. Kidney function deteriorates with age. It might be possible that kidney donation initiates this effect at a younger age, or accelerates this effect in general. This, in turn, may lead to the manifestation of kidney related disease such as diabetes, hypertension and other cardiovascular diseases.

The effects of becoming uninephric have been studied in World War II veterans and in kidney donors as well. These studies suggested that live kidney have no additional risk of becoming patients themselves. However, as kidney function and kidney related disease correlates with age and gender, it is very important to compare this group to a representative control group. All studies performed on this subject so far, have failed to do this. The Rotterdam Study is a prospective, population-based cohort study. The aim of the Rotterdam Study is to investigate factors that determine the occurrence of cardiovascular, neurological, ophthalmological, endocrinological, and psychiatric diseases in elderly people. The study was established in 1990 and prospectively follows the inhabitants of the city Ommoord, a suburb of Rotterdam. The incidence of cardiovascular and renal disease is monitored, as well as kidney function and many other factors. For this reason, the Rotterdam Study can serve as an ideal control group for a population of live kidney donors. When donors of a certain gender and age are matched to a control of the same gender and age, the effects of donation can be objectively studied.

The aim of this study is to assess the long-term effects of live kidney donation, especially in elderly donors or donors with minor comorbidities. Also, the effect of live kidney donation at a higher age on quality of life will be assessed.
- Main changes (audit trail)
- RECORD17-jan-2013 - 9-feb-2013

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