NCT04226859

Brief Summary

The gold standard for characterizing chronic kidney disease (CKD) is the glomerular filtration rate (GFR), which is commonly estimated in both native and transplanted kidneys for patient monitoring and therapeutic management and ultimately guides decision-making about whether a patient needs renal replacement therapy. In particular, the National Kidney Foundation has defined CKD stages according to estimated GFR (eGFR) values and in several studies, the eGFR slope or change has been found to be strongly associated with end stage renal disease (ESRD). However, little is known about the heterogeneity of eGFR evolution in time - i.e. eGFR trajectories - and the related progression to ESRD and death. To date, no studies have investigated eGFR trajectories in diversified cohorts and populations worldwide, although this approach could provide a better understanding of CKD evolution and hence improve risk stratification. In addition, determinants of eGFR trajectories remain poorly described. An unsupervised approach could allow examining eGFR trajectories over time and could lead to the identification of patient groups according to the probability of the progression of their kidney disease. Therefore, this study aims:

  1. 1.To identify the long-term eGFR trajectories after kidney transplantation using latent class mixed models;
  2. 2.To identify the clinical, immunological, histological and functional determinants of the eGFR trajectories using multinomial regressions;
  3. 3.To investigate the associations of the eGFR trajectories with the progression to ESRD and death.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
4 countries

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
20 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

20.4 years

First QC Date

January 9, 2020

Last Update Submit

January 13, 2020

Conditions

Kidney Transplant FailureKidney Function Issue

Keywords

Kidney TransplantationGraft SurvivalGlomerular Filtration RateTrajectories

Outcome Measures

Primary Outcomes (1)

  • eGFR trajectories

    eGFR trajectories probabilities, calculated from a prediction system (based on clinical, histological, immunological, and functional factors) assessed at 1-year post transplantation.

    Up to 10 years after kidney transplantation

Interventions

No interventionOTHER

Kidney recipients aged over 18 and of all sexes recruited from 2000 in European and North American centers, who have eGFR follow-up and data from protocol and for cause biopsies available for allograft survival assessment; Randomized controlled trials conducted over the past 20 years with available data on protocol biopsy within the first year and follow up clinical, biological and histological data.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Kidney recipients aged over 18 and of all sexes recruited from 2000 in European and North American centers, who have eGFR repeated measurements, data from protocol and for cause biopsies, as well as immunological, clinical, functional parameters and survival data for allograft and patient survival assessment. Additional kidney recipients from RCTs with longitudinal data including baseline and follow-up clinical, functional, immunological and histological data.

You may qualify if:

  • Kidney recipients transplanted after 2000
  • Kidney recipients over 18 years of age
  • Kidney recipients with at least two eGFR measurements after transplantation

You may not qualify if:

  • Combined transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Department of Medicine, Division of Nephrology, Comprehensive Transplant Center, Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

ENROLLING BY INVITATION

Department of Surgery, Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

ENROLLING BY INVITATION

William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic

Rochester, Minnesota, 55905, United States

ENROLLING BY INVITATION

Albert Einstein College of Medicine, Renal Division Montefiore Medical Center, Kidney Transplantation Program

New York, New York, 10467, United States

ENROLLING BY INVITATION

Virginia Commonwealth University School of Medicine

Richmond, Virginia, 980663, United States

ENROLLING BY INVITATION

Department of Nephrology and Renal Transplantation, University Hospitals Leuven

Leuven, 3000, Belgium

ENROLLING BY INVITATION

Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School od Medicine University of Zagreb

Zagreb, 10000, Croatia

ENROLLING BY INVITATION

Department of Nephrology, Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295, France

ENROLLING BY INVITATION

Nephrology Dialysis Transplantation Department, University of Lorraine, Centre Hospitalier Universitaire de Nancy

Nancy, 54035, France

ENROLLING BY INVITATION

Centre Hospitalier Universitaire de Nantes

Nantes, 44093, France

ENROLLING BY INVITATION

Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris

Paris, 75010, France

RECRUITING

Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris

Paris, 75015, France

RECRUITING

Department of Transplantation, Nephrology and Clinical Immunology, Hôpital Foch

Suresnes, 92150, France

ENROLLING BY INVITATION

Department of Nephrology and Organ Transplantation, Centre Hospitalier Universitaire Rangueil

Toulouse, 31059, France

ENROLLING BY INVITATION

Bretonneau Hospital, Nephrology and Immunology Department

Tours, 37000, France

ENROLLING BY INVITATION

Related Links

Study Officials

  • Alexandre Loupy, Professor

    Paris Translational Research Center for Organ Transplantation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Loupy, Professor

CONTACT

alexandre.loupy@inserm.fr

Marc Raynaud

CONTACT

+33613493009mrayna06@gmail.com

Study Design

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

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 13, 2020

Study Start

January 1, 2000

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(8)US(5)BE(1)CR(1)