The assessment of microvascular alterations in renal transplant recipients with and without rejection

The assessment of microvascular alterations in renal transplant recipients with and without rejection - OPS-1

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33397

Enrollment

105

Registered

2009-11-18

Start date

2010-02-19

Completion date

Unknown

Last updated

2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronische allograft nefropathie rejection

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for renal transplant patients: 1. Age: 18 -70 years 2. Female or male 3. Kidney transplantation( living and cadaveric) 4. Patients who will undergo renal biopsy because of renal function impairment 5. Patients must be able to adhere to the study visit schedule and protocol requirements. 6. Patients must be able to give informed consent and the consent must be obtained prior to any study procedure.;Inclusion criteria for healthy controls: 1. Age: 18-70 2. Female or male

Exclusion criteria

Exclusion criteria: Exclusion criteria for renal transplant patients: 1. Double organ transplantation 2. Patients with evidence of active infection or abcesses. 3. Patients suffering from hepatic failure. 4. Patients suffering from an active autoimmune disease 5. Malignancy (including lymphoproliferative disease) within the past 2-5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence) 6. Patients who currently have an active opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus (CMV), Pneumocystis carinii (PCP), aspergillosis, histoplasmosis, or mycobacteria other than TB) 7. Patients with epilepsy;Exclusion criteria for healthy controls: 1. Smoking (within 1 year prior to screening) 2. History of cardiovascular disease 3. History of malignancy 4. Use of any investigational agent in the last 30 days 5. History of chronic inflammatory disease 6. History of chronic skin diseases 7. History of diabetes mellitus 8. History of alcohol or drug abuse within the last 5 years 9. Hypertension

Design outcomes

Primary

Measure	Time frame
1. Non- invasive assessment of microvascular structure using OPS in patients with and without rejection	—

Secondary

Measure	Time frame
1. Correlation of microvascular alterations and markers for endothelial dysfunction, fibrosis and histology 2. Correlation of microvascular alterations and renal function 3. Correlation of microvascular alterations and graft survival	—

Countries

Netherlands

Outcome results