Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06056466
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2023-07-14
Brief Title:
Different Vascular and Renal Parameters in Living Kidney Donors
Sponsor:
University of Erlangen-Nürnberg Medical School
Organization:
University of Erlangen-Nürnberg Medical School
Study Overview
Official Title:
A Prospective Observational Non-interventional Single-center Study to Analyze the Relationship Between Different Vascular and Renal Parameters in Living Kidney Donors With 1 Year Follow-up
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic kidney disease CKD has a high prevalence globally and is a global health concern CKD is associated with increased risks of cardiovascular morbidity mortality and therefore decreased quality of life in any stage of the disease CKD in early stage is often asymptomatic which makes the detection of the disease difficult
In this study our goal is to analyze in a clinical trial to what extend renal and vascular parameters correlate with histological kidney changes especially in a population with eGFR rate of more than 60 mLmin173 m² or pseduonormalized renal function Our crossectional analysis focus on the association of abnormal vascular and renal parameters with histological renal changes Our longitudinal analysis focus on the association of histological with renal andor vascular parameters at baseline with the renal outcome after kidney donation
Different renal and vascular parameters are obtained non-invasively in potential living kidney donors before donation Preimplantation kidney biopsies are obtained routinely during donation which is a standard procedure of our living kidney donation programme The living kidney donors will be followed up in respect to renal function and blood pressure for one year after donation
Our hypothesis is that histological scoring of renal damage total renal chronicity scores correlates with vascular parameters indicating increased stiffness The primary vascular parameter is wall to lumen ratio of retinal arterioles Moreover the investigators hypothesize that vascular parameters predicts 24-hour blood pressure and renal outcome eGFR albuminuria one year after donation To prove this hypothesis overall the investigators will include 25 subjects in this study having been evaluated before as potential living kidney donors Total duration of this study for each volunteer is 15 months with total 5 visits of which 4 are at the Clinical Research Unit CRC of the Department of Nephrology University of Erlangen-Nuremberg and one is the day of kidney donation
This study is important to detect renal damage or CKD in patients with eGFR rate of more than 60 mLmin173 m² or pseduonormalized renal function CKD stage 1 or 2
In this study our goal is to analyze in a clinical trial to what extend renal and vascular parameters correlate with histological kidney changes especially in a population with eGFR rate of more than 60 mLmin173 m² or pseduonormalized renal function Our crossectional analysis focus on the association of abnormal vascular and renal parameters with histological renal changes Our longitudinal analysis focus on the association of histological with renal andor vascular parameters at baseline with the renal outcome after kidney donation
Different renal and vascular parameters are obtained non-invasively in potential living kidney donors before donation Preimplantation kidney biopsies are obtained routinely during donation which is a standard procedure of our living kidney donation programme The living kidney donors will be followed up in respect to renal function and blood pressure for one year after donation
Our hypothesis is that histological scoring of renal damage total renal chronicity scores correlates with vascular parameters indicating increased stiffness The primary vascular parameter is wall to lumen ratio of retinal arterioles Moreover the investigators hypothesize that vascular parameters predicts 24-hour blood pressure and renal outcome eGFR albuminuria one year after donation To prove this hypothesis overall the investigators will include 25 subjects in this study having been evaluated before as potential living kidney donors Total duration of this study for each volunteer is 15 months with total 5 visits of which 4 are at the Clinical Research Unit CRC of the Department of Nephrology University of Erlangen-Nuremberg and one is the day of kidney donation
This study is important to detect renal damage or CKD in patients with eGFR rate of more than 60 mLmin173 m² or pseduonormalized renal function CKD stage 1 or 2
Detailed Description:
Chronic kidney disease CKD has a high prevalence globally and is a global health concern KDIGO-Guidelines describes CKD as an abnormality of kidney function or structure present more than 3 months with implications for the health of an individual CKD is associated with increased risks of cardiovascular morbidity mortality and decreased quality of life in all stages of the disease Most patients with CKD will die of cardiovascular event in earlier stages before end-stage renal disease develops CKD in early stage is often asymptomatic which makes the detection of the disease difficult Early detection of CKD could delay or even prevent the associated complications and the progression to kidney failure through appropriate control of cardiovascular risk factors
The glomerular filtration rate GFR is widely accepted as an overall index of kidney function and is considered for the classification of CKD A GFR rate of more than 60 mLmin173 m² is considered only as abnormal if it is accompanied by albuminuria urine sediment abnormalities structural abnormalities detected by imaging tests or if the patient has had a kidney biopsy with histological abnormalities Since kidney biopsy is not done in all patients with respect to risk of the procedure diagnosis of CKD stage 1 and 2 is difficult
Moreover an association of abnormal increase in GFR with all-cause mortality has also been recently described This process of glomerular hyperfiltration may lead to pseudonormalization of the renal function and is associated with various medical conditions such as diabetes hypertension as well as lifestyle factors such as smoking and lack of physical activity The influence of intrauterine environment in the development of low nephron number leading to glomerular hyperfiltration and glomerular enlargement has been also described These maladaptive changes may then eventually lead to the development of glomerular and systemic hypertension and renal disease in later life
In this study our goal is to analyze in a clinical trial to what extend renal and vascular parameters correlate with histological kidney changes especially in subjects with eGFR rate of more than 60 mLmin173 m² or pseduonormalized renal function Different renal and vascular parameters are obtained non-invasively in potential living kidney donors before donation Kidney biopsies are obtained routinely after nephrectomy and before implantation pre-implantation biopsy Kidney biopsy samples can demonstrate definitive evidence of CKD through common histological changes Our crosssectional analysis focus on the association of abnormal vascular and renal parameters with histological renal changes The living kidney donors will be followed up in respect to renal function and blood pressure for one year after donation Our longitudinal analysis focus on the association of histological with renal andor vascular parameters at baseline with the renal outcome eGFR albuminuria 24-hour blood pressure after kidney donation
This study is a single-centre clinical study with 25 potential kidney donors This is an exploratory and non-confirmatory study in which the investigators analyse different vascular and renal parameters in potential kidney donors before donation and a kidney biopsy sample is obtained during donation
Our hypothesis is that histological scoring of renal damage total renal chronicity scores correlates with vascular parameters indicating increased stiffness The primary vascular parameter is wall to lumen ratio of retinal arterioles Moreover the investigators hypothesize that vascular parameters predicts 24-hour blood pressure and renal outcome eGFR albuminuria one year after donation
This study is a single-center clinical study at the Clinical Research Unit CRC of the Department of Nephrology and Hypertension Erlangen Ulmenweg 18 91054 Erlangen INZ University Hospital Erlangen
After approval of the trial protocol by the local ethics committee University of Erlangen-Nuremberg participants will be recruited from the transplantation center of Erlangen-Nuremberg Germany Eligible participants will be screened according to the inclusion and exclusion criteria on Visit 1 after approval of donation by immunological psychological medical evaluation and positive vote of the living donation commission Subsequently suitable participants will be included in the trial after written informed consent has been obtained The trial will be conducted in accordance with the Declaration of Helsinki and the principles of good clinical practice guidelines
Demographic data safety parameters eg creatinine liver enzymes ECG and urine examination are obtained on visit 1 On the same day office BP and heart rate measurements are taken in a seated position after 5 min of rest according to guideline recommendations
On visit 2 the subjects will be instructed to fast and abstain from alcohol caffeine and antioxidant vitamins The primary objective of this trial will be obtained on visit 2 in 25 potential kidney donors On visit 2 vascular assessment including pulse wave analysis and velocity as well as flow mediated dilation FMD measurement will be performed Retinal capillary flow RCF and structural and functional vascular changes of retinal arterioles will be assessed by Scanning Laser Doppler Flowmetry SLDF measurement Resistance index of intrarenal arteries will be determined by renal duplex sonography In patients without contraindications for MRI examination ASL-MRI and 23Na-MRI will be performed on the same day Blood samples will be drawn after lying half an hour in supine position to analyse renal eGFR Cystatin C and endocrine renin angiotensin aldosterone parameters Urine samples will be collected to assess UACR At the end of visit a container will be handed over to the subject to collect urine for 24 hours to assess UACR sodium potassium and creatinine
On the day of kidney donation visit 3 a kidney biopsy sample will be obtained after explantation of the kidney which is a standard procedure of our living kidney donor programme Histological analysis and scoring of chronic changes such as global and segmental glomerulosclerosis tubular atrophy interstitial fibrosis and arteriosclerosisarteriolosclerosis of the biopsy specimen will be performed
The living kidney donors will be followed up according to our standard living kidney post-donation programme visit 4 and 5 in respect to renal function eGFR CKD-Epi Cystatin C UACR blood pressure office and 24h ambulatory blood pressure and endocrine parameters renin angiotensin aldosterone for one year after donation If feasible 24h-urine will be collected to re-assess parameters mentioned above All assessments measured at visit 2 except measurement of FMD and measurement of resistance index of intrarenal arteries will be remeasured at visit 4 Safety parameters and adverse events will be recorded at all visits
The glomerular filtration rate GFR is widely accepted as an overall index of kidney function and is considered for the classification of CKD A GFR rate of more than 60 mLmin173 m² is considered only as abnormal if it is accompanied by albuminuria urine sediment abnormalities structural abnormalities detected by imaging tests or if the patient has had a kidney biopsy with histological abnormalities Since kidney biopsy is not done in all patients with respect to risk of the procedure diagnosis of CKD stage 1 and 2 is difficult
Moreover an association of abnormal increase in GFR with all-cause mortality has also been recently described This process of glomerular hyperfiltration may lead to pseudonormalization of the renal function and is associated with various medical conditions such as diabetes hypertension as well as lifestyle factors such as smoking and lack of physical activity The influence of intrauterine environment in the development of low nephron number leading to glomerular hyperfiltration and glomerular enlargement has been also described These maladaptive changes may then eventually lead to the development of glomerular and systemic hypertension and renal disease in later life
In this study our goal is to analyze in a clinical trial to what extend renal and vascular parameters correlate with histological kidney changes especially in subjects with eGFR rate of more than 60 mLmin173 m² or pseduonormalized renal function Different renal and vascular parameters are obtained non-invasively in potential living kidney donors before donation Kidney biopsies are obtained routinely after nephrectomy and before implantation pre-implantation biopsy Kidney biopsy samples can demonstrate definitive evidence of CKD through common histological changes Our crosssectional analysis focus on the association of abnormal vascular and renal parameters with histological renal changes The living kidney donors will be followed up in respect to renal function and blood pressure for one year after donation Our longitudinal analysis focus on the association of histological with renal andor vascular parameters at baseline with the renal outcome eGFR albuminuria 24-hour blood pressure after kidney donation
This study is a single-centre clinical study with 25 potential kidney donors This is an exploratory and non-confirmatory study in which the investigators analyse different vascular and renal parameters in potential kidney donors before donation and a kidney biopsy sample is obtained during donation
Our hypothesis is that histological scoring of renal damage total renal chronicity scores correlates with vascular parameters indicating increased stiffness The primary vascular parameter is wall to lumen ratio of retinal arterioles Moreover the investigators hypothesize that vascular parameters predicts 24-hour blood pressure and renal outcome eGFR albuminuria one year after donation
This study is a single-center clinical study at the Clinical Research Unit CRC of the Department of Nephrology and Hypertension Erlangen Ulmenweg 18 91054 Erlangen INZ University Hospital Erlangen
After approval of the trial protocol by the local ethics committee University of Erlangen-Nuremberg participants will be recruited from the transplantation center of Erlangen-Nuremberg Germany Eligible participants will be screened according to the inclusion and exclusion criteria on Visit 1 after approval of donation by immunological psychological medical evaluation and positive vote of the living donation commission Subsequently suitable participants will be included in the trial after written informed consent has been obtained The trial will be conducted in accordance with the Declaration of Helsinki and the principles of good clinical practice guidelines
Demographic data safety parameters eg creatinine liver enzymes ECG and urine examination are obtained on visit 1 On the same day office BP and heart rate measurements are taken in a seated position after 5 min of rest according to guideline recommendations
On visit 2 the subjects will be instructed to fast and abstain from alcohol caffeine and antioxidant vitamins The primary objective of this trial will be obtained on visit 2 in 25 potential kidney donors On visit 2 vascular assessment including pulse wave analysis and velocity as well as flow mediated dilation FMD measurement will be performed Retinal capillary flow RCF and structural and functional vascular changes of retinal arterioles will be assessed by Scanning Laser Doppler Flowmetry SLDF measurement Resistance index of intrarenal arteries will be determined by renal duplex sonography In patients without contraindications for MRI examination ASL-MRI and 23Na-MRI will be performed on the same day Blood samples will be drawn after lying half an hour in supine position to analyse renal eGFR Cystatin C and endocrine renin angiotensin aldosterone parameters Urine samples will be collected to assess UACR At the end of visit a container will be handed over to the subject to collect urine for 24 hours to assess UACR sodium potassium and creatinine
On the day of kidney donation visit 3 a kidney biopsy sample will be obtained after explantation of the kidney which is a standard procedure of our living kidney donor programme Histological analysis and scoring of chronic changes such as global and segmental glomerulosclerosis tubular atrophy interstitial fibrosis and arteriosclerosisarteriolosclerosis of the biopsy specimen will be performed
The living kidney donors will be followed up according to our standard living kidney post-donation programme visit 4 and 5 in respect to renal function eGFR CKD-Epi Cystatin C UACR blood pressure office and 24h ambulatory blood pressure and endocrine parameters renin angiotensin aldosterone for one year after donation If feasible 24h-urine will be collected to re-assess parameters mentioned above All assessments measured at visit 2 except measurement of FMD and measurement of resistance index of intrarenal arteries will be remeasured at visit 4 Safety parameters and adverse events will be recorded at all visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None