Contribution of Renal Function to Endothelial Dysfunction in Living Kidney Donors and Transplant Recipients

NCT02515643 | Unknown

• 1 other identifier: PR(AG)219/2014
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

Endothelial dysfunction one-year after transplantation mainly depends on transplant-associated factors and only marginally on reduced renal function. OBJETIVES Primary objective Estimate the contribution of renal dysfunction to endothelial dysfunction in two cohorts of patients, living kidney donors and their transplant recipients. Secondary objectives To evaluate in both cohorts of patients before and after nephrectomy/transplantation the evolution of the following parameters:

1. 1.Renal function (iohexolGFR, proteinuria/microalbuminuria).
2. 2.Blood pressure (24 h ambulatory blood pressure measurement)
3. 3.Surrogate variables of subclinical atherosclerosis (carotid ultrasound, ankle-brachial index, pulse wave velocity).

Conditions

Disorder Related to Renal Transplantation; Chronic Kidney Disease; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

• Percentual change of sVCAM

  Biomarker of endothelial dysfunction: Soluble VCAM (vascular cell adhesion molecule). Determination of serum levels by Luminex. Percentual change between baseline and 1 year levels.

  1 year

Secondary Outcomes (14)

• Glomerular filtration rate

  1 year

• Microalbuminuria

  1 year

• Blood pressure (24 h ambulatory blood pressure measurement)

  1 year

• Number of carotid plaques and carotid intima-media thickness

  1 year

• Pulse wave velocity.

  1 year

Study Arms (2)

Endothelial dysfunction in Cohort 1

Assessment of endothelial dysfunction in healthy subjects who will undergo a nephrectomy as part of the living donor program at each participating center.

Other: Endothelial dysfunction

Endothelial dysfunction in Cohort 2

Assessment of endothelial dysfunction in renal transplant recipients from cohort 1

Other: Endothelial dysfunction

Interventions

Endothelial dysfunction OTHER

One month before surgery and one year after, the following procedures will be performed in donors and recipients: 1. Blood samples will be obtained for the measurement of endothelial dysfunction and low grade inflammation markers. 2. Atherosclerotic burden: carotid ultrasound to determine the number of plaques and intima-media thickness, carotid-femoral pulse wave velocity (m/s) will be performed by pulse tonometry. 3. Ambulatory blood pressure monitoring with overnight-automated ABPM monitor 4. Estimation of glomerular filtration rate by Iohexol method

Endothelial dysfunction in Cohort 1; Endothelial dysfunction in Cohort 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort 1 Healthy subjects who will undergo a nephrectomy as part of the living donor program at each participating center. Cohort 2 Renal transplant recipients from cohort 1

You may qualify if:

• No history of familiar nephropathies and/other diseases that may increase the risk for renal disease in the future.
• Donor age ≥ 18 years
• Isotopic GFR \> 80 ml/min/1.73m2
• Microalbuminuria\< 30 mg/g
• Normal urinary sediment
• Normal blood pressure defined as \<120/90 mmHg and without other risk factors for cardiovascular disease, and with good/normal kidney function or well-controlled hypertension with one anti-hypertensive drug,
• No previous history of diabetes including gestational diabetes and fasting glucose \< 126 mg/dl and 2h serum glucose after 75 g oral glucose tolerance test \< 200 mg/dl
• Signed informed consent
• Chronic kidney disease stage 5
• Negative complement dependent lymphocytotoxicity donor-recipient cross-match.
• Informed signed consent

You may not qualify if:

• History of cancer except non-melanoma cutaneous neoplasia
• History of vasculitis (e.g. lupus), sarcoidosis, gastrointestinal inflammatory diseases, autoimmune-disease
• History of major cardiovascular events
• History of deep vein thrombosis or pulmonary embolism.
• Active infection including hepatitis B, C and HIV infections.
• Anatomic vascular variants precluding laparoscopic nephrectomy
• Renal stones except a solitary lithiasis\< 1.5 cm once metabolic disorders are ruled out
• Major psychiatric disorders
• Active alcohol, tobacco or drug abuse
• Obesity defined as body mass index \> 35 kg/m2.
• Pregnancy
• Glomerulonephritis with high recurrence rate after transplantation (focal segmental glomerulosclerosis and type II membranoproliferative glomerulonephritis)
• Severe aortoiliac atherosclerosis precluding transplantation
• Major psychiatric disorders
• Alcohol and drug abuse

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Teva Pharmaceutical Industries, Ltd.: collaborator

Study Sites (4)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

RECRUITING

Vall d'Hebron Research Institute

Barcelona, Barcelona, 08035, Spain

RECRUITING

Hospital Universitario Canarias

Santa Cruz de Tenerife, Canary Islands, 38320, Spain

NOT YET RECRUITING

Hospital Regional Universitario Carlos Haya

Málaga, Malaga, 29010, Spain

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francesc Moreso, MD, PhD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesc Moreso, MD, PhD

CONTACT

+34932746079; fjmoreso@vhebron.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: August 5, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 28, 2017

Record last verified: 2017-03

Locations

ES (4)