Prediction of Chronic Allograft Nephropathy

NCT01380847 | Completed

• 1 other identifier: NI 09045
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators have shown that epithelial-to-mesenchymal transition (EMT) markers in early protocol biopsies of the renal allograft predicts the progression of fibrosis during the first year post-transplantation. The investigators will develop a non-invasive approach for predicting fibrosis as a substitute for the invasive allograft biopsy procedure, by longitudinal assessment of the mRNA expression level of genes implicated in EMT/fibrogenesis and inflammation in urinary cells from kidney transplant recipients during the first year post-transplantation.

Conditions

Kidney Transplantation; Kidney Disease; Kidney Failure, Chronic

Keywords

Kidney Transplantation; Allograft; Kidney failure; Chronic allograft nephropathy; Monitoring; Urine

Outcome Measures

Primary Outcomes (1)

• Renal allograft fibrosis

  Renal allograft fibrosis at one year posttransplantation

  2 years

Secondary Outcomes (1)

• Renal allograft nephropathy

  4 years

Study Arms (1)

Renal allograft nephropathy

To evaluate urine from KTRs during the first year post-transplantation to assess whether mRNA levels of genes involved in EMT/fibrogenesis can diagnose and predict CAN, and identify patients at risk of chronic allograft dysfunction

Genetic: mRNAs encoding genes

Interventions

mRNAs encoding genes GENETIC

investigate whether the levels of 21 mRNAs encoding genes involved in EMT/fibrogenesis and the alloimmune response are a sensitive and specific non-invasive diagnostic test for CAN in renal allografts

Renal allograft nephropathy

Eligibility Criteria

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

Study Population

Hospitalized patients from Necker Hospital

You may qualify if:

• male and female adult recipients
• patients undergoing primary or re-do deceased-donor or living-donor kidney transplantation
• ability to provide informed consent

You may not qualify if:

• patients undergoing combined organ transplantation
• Contraindication to protocol allograft biopsy
• Inability or unwillingness of a participant to provide informed consent.
• HCV infected
• HIV infected

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Fondation Centaure: collaborator
• ROTRF: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Necker Hospital

Paris, 75015, France

Location

Related Publications (1)

• Galichon P, Amrouche L, Hertig A, Brocheriou I, Rabant M, Xu-Dubois YC, Ouali N, Dahan K, Morin L, Terzi F, Rondeau E, Anglicheau D. Urinary mRNA for the Diagnosis of Renal Allograft Rejection: The Issue of Normalization. Am J Transplant. 2016 Oct;16(10):3033-3040. doi: 10.1111/ajt.13891. Epub 2016 Jul 8.

  PMID: 27232948 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

RNA profiling of urinary cells in kidney transplant recipients

MeSH Terms

Conditions

Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

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

Study Officials

• Dany Anglicheau, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: June 27, 2011
• Study Start: June 1, 2011
• Primary Completion: April 19, 2012
• Study Completion: April 19, 2012
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

FR (1)