Renal Injury Clinical Trial
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
NCT number | NCT06056466 |
Other study ID # | CRC2018Tx |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 8, 2019 |
Est. completion date | March 31, 2024 |
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 mL/min/1.73 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 and/or 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 mL/min/1.73 m² or pseduonormalized renal function (CKD stage 1 or 2).
Status | Recruiting |
Enrollment | 25 |
Est. completion date | March 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 85 Years |
Eligibility | Inclusion Criteria: - Age of 30 - 85 years - Male and Female patients - Persons (evaluated and accepted for kidney donation) in good and stable health condition with eGFR>60 ml/min/1.73m² - Informed consent has to be given in written form Exclusion Criteria: - Type-2-diabetes or any other form of diabetes (fasting plasma glucose = 126 mg/dl, HbA1c = 6,5%, post prandial glucose = 200 mg/dl * - Uncontrolled arterial hypertension (= 180/110 mmHg) * - Any history of stroke, transient ischemic attack, instable angina pectoris or myocardial infarction within the last 6 months prior to study inclusion * - Estimated glomerular filtration rate = 60 ml/min/1.73m² * - Significant laboratory abnormalities such as Serum Glutamate-Oxaloacetate-Transaminase (SGOT) or Serum Glutamate-Pyruvate-Transaminase (SGPT) levels more than 3 times above the upper limit of normal range * - Patients in unstable conditions due to any kind of serious disease, that infers with the conduction of the trial * - Patients suffering from cataract or glaucoma + - Diabetic retinopathy * - active Drug or alcohol abuse * - Pregnant and breast-feeding patients * - Body mass index > 33 kg/m² * - Participation in another clinical study within 30 days prior to visit 1+ - Subjects who do not give written consent, that pseudonymous data will be transferred in line with the duty of documentation and the duty of notification according to § 12 and § 13 GCP-V + For patients undergoing 23Na- and ASL-MRI: - Implanted pacemakers or defibrillators + - Other implanted metallic devices, which are not MRI compatible + - Claustrophobia + - Any other relevant clinical contraindication of MRI examination + - Please note that these exclusion criteria are also exclusion criteria of our kidney donation programme + These exclusions are due to the study, in particular due to methods we apply at visit 2 |
Country | Name | City | State |
---|---|---|---|
Germany | Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg | Erlangen |
Lead Sponsor | Collaborator |
---|---|
University of Erlangen-Nürnberg Medical School |
Germany,
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Park M, Yoon E, Lim YH, Kim H, Choi J, Yoon HJ. Renal hyperfiltration as a novel marker of all-cause mortality. J Am Soc Nephrol. 2015 Jun;26(6):1426-33. doi: 10.1681/ASN.2014010115. Epub 2014 Oct 24. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wall to lumen ratio of retinal arterioles assessed by SLDF | The primary objective of the study is to analyze wall to lumen ratio of retinal arterioles before kidney donation and 6 months after donation | within 8 weeks before donation, 6 months after donation | |
Secondary | Retinal capillary flow determined by SLDF measurement | change in retinal capillary flow 6 months after kidney donation | within 8 weeks before donation, 6 months after donation | |
Secondary | Central systolic pressure assessed by Sphygmocor XCEL | change in central systolic pressure 6 months after kidney donation | within 8 weeks before donation, 6 months after donation | |
Secondary | Pulse pressure assessed by Sphygmocor XCEL | change in pulse pressure 6 months after kidney donation | within 8 weeks before donation, 6 months after donation | |
Secondary | Pulse wave velocity assessed by Sphygmocor XCEL | change in pulse wave velocity 6 months after kidney donation | within 8 weeks before donation, 6 months after donation | |
Secondary | Augmentation index assessed by Sphygmocor XCEL | change in augmentation index 6 months after kidney donation | within 8 weeks before donation, 6 months after donation | |
Secondary | 24-h ambulatory vascular parameter assessed by Mobil-O-Graph | change of 24-h ambulatory vascular parameter (pulse wave velocity) 6 months and 1 year after kidney donation | within 8 weeks before donation, 6 months after donation, 1 year after donation | |
Secondary | Flow mediated vasodilation as measured by semi-automated ultrasound system (% vasodilation from baseline) with the UNEX system | change of flow mediated vasodilation 6 months after kidney donation | within 8 weeks before donation, 6 months after donation | |
Secondary | Renal perfusion of both kidneys assessed by Arterial Spin Labeling MRI | change of renal perfusion (total, cortical, medullary) 6 months after kidney donation | within 8 weeks before donation, 6 months after donation | |
Secondary | Skin sodium content (23Na-MRI) assessed at the lower leg | change of Skin sodium content 6 months after kidney donation | within 8 weeks before donation, 6 months after donation | |
Secondary | Muscle sodium content (23Na-MRI) assessed at the lower leg | change of muscle sodium content 6 months after kidney donation | within 8 weeks before donation, 6 months after donation | |
Secondary | Resistance index determined by renal duplex sonography | change of resistance index 6 months after kidney donation | within 8 weeks before donation, 6 months after donation | |
Secondary | 24-h ambulatory blood pressure assessed by Mobil-O-Graph | change of 24-h blood pressure 6 months and 1 year after kidney donation | within 8 weeks before donation, 6 months after donation, 1 year after donation | |
Secondary | estimated glomerular filtration rate (CKD-Epi) assessed in our central lab | change of estimated glomerular filtration rate (CKD-Epi) 6 months and 1 year after kidney donation | within 8 weeks before donation, 6 months after donation, 1 year after donation | |
Secondary | Cystatin C assessed in our central lab | change of Cystatin C 6 months and 1 year after kidney donation | within 8 weeks before donation, 6 months after donation, 1 year after donation | |
Secondary | UACR in spot urine and 24-h urine assessed in our central lab | change of UACR 6 months and 1 year after kidney donation | within 8 weeks before donation, 6 months after donation, 1 year after donation | |
Secondary | Global and segmental glomerulosclerosis (histological analyses of the kidney sample) | Global and segmental glomerulosclerosis analyzed histologically in a kidney biopsy sample obtained after explantation of the kidney.
Minimum value=0, maximum value=3. Subjective histological assessment based on grade of glomerular sclerosis. |
within 8 weeks after assessing primary outcome measure | |
Secondary | Tubular atrophy (histological analyses of the kidney sample) | Tubular atrophy analyzed histologically in a kidney biopsy sample obtained after explantation of the kidney.
Minimum value=0, maximum value=3. Subjective histological assessment based on grade of tubular atrophy. |
within 8 weeks after assessing primary outcome measure | |
Secondary | Interstitial fibrosis (histological analyses of the kidney sample) | Interstitial fibrosis analyzed histologically in a kidney biopsy sample obtained after explantation of the kidney.
Minimum value=0, maximum value=3. Subjective histological assessment based on grade of fibrosis. |
within 8 weeks after assessing primary outcome measure | |
Secondary | Arteriosclerosis/arteriolosclerosis (histological analyses of the kidney sample) | Arteriosclerosis/arteriolosclerosis analyzed histologically in a kidney biopsy sample obtained after explantation of the kidney.
Minimum value=0 (Intima thickness less than thickness of media), maximum value=1 (Intima thickness greater than thickness of media) |
within 8 weeks after assessing primary outcome measure | |
Secondary | Total renal chronicity score (histological analyses of the kidney sample) | Total renal chronicity score assessed histologically after explantation of the kidney.
Minimum value=0 (better outcome), maximum value=10 (worse outcome) |
within 8 weeks after assessing primary outcome measure |
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