Evaluation of CAF22 After Renal Transplantation

NCT02346968 | Completed

• 1 other identifier: 98/14
• Study Type: observational
• Target: 99
• Locations: 2 countries
• Sites: 2

Brief Summary

Established markers of kidney function, such as creatinine, have considerable limitations in the diagnosis of delayed graft function (DGF) after kidney transplantation (KT). Indeed, creatinine does not accurately reflect minor changes of renal function as its levels change only upon significant fluctuations of the latter. CAF22 is a molecule which arises from the degradation of a larger protein and it is proposed to be a reliable and more sensitive marker of renal function. This study aims to further clarify this issue by measuring blood and urine concentrations of CAF22 and comparing them with creatinine levels before and after KT. The main assumption is that blood CAF22 levels could serve as a more sensitive kidney function biomarker than creatinine post-KT to detect DGF.

Conditions

Kidney Transplantation; Delayed Graft Function

Keywords

Kidney Transplantation; Delayed Graft Function; C-terminal fragment of agrin; Dialysis

Outcome Measures

Primary Outcomes (1)

• Delayed graft function (DGF) defined as the requirement of dialysis within 7 days after transplantation

  7 days

Secondary Outcomes (3)

• Immediate graft function (IGF)

  7 days

• Need for hemodialysis

  7 days

• Hemodialysis duration (in days)

  7 days

Study Arms (1)

All study participants

Patients with end stage renal disease (ESRD) planned to undergo kidney transplantation.

Other: Blood and urine sampling

Interventions

Blood and urine sampling OTHER

Blood and urine sampling (in the context of routine sampling)

All study participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with end stage renal disease (ESRD) planned to undergo kindey transplantation in Bern University Hospital will be screened consecutively, informed and asked for written inform consent.

You may qualify if:

• Age ≥ 18 years old
• Written informed consent
• All patients planned to undergo kidney transplantation

You may not qualify if:

• Age \<18 years old
• Pregnancy
• Other individuals especially in need of protection (according to the Swiss Academy of Medical Sciences)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (2)

Department of Nephrology, University Hospital of Essen

Essen, 45147, Germany

Location

Dep. of Nephrology, Bern University Hospital

Bern, 3010 Bern, Switzerland

Location

Related Publications (5)

• Steubl D, Hettwer S, Vrijbloed W, Dahinden P, Wolf P, Luppa P, Wagner CA, Renders L, Heemann U, Roos M. C-terminal agrin fragment--a new fast biomarker for kidney function in renal transplant recipients. Am J Nephrol. 2013;38(6):501-8. doi: 10.1159/000356969. Epub 2013 Dec 14.

  PMID: 24356308 BACKGROUND

• Steubl D, Hettwer S, Dahinden P, Wolf P, Luppa P, Wagner CA, Kuchle C, Schmaderer C, Renders L, Heemann U, Roos M. Influence of high-flux hemodialysis and hemodiafiltration on serum C-terminal agrin fragment levels in end-stage renal disease patients. Transl Res. 2014 Nov;164(5):392-9. doi: 10.1016/j.trsl.2014.05.005. Epub 2014 May 16.

  PMID: 24907476 BACKGROUND

• Steubl D, Hettwer S, Dahinden P, Luppa P, Rondak IC, Regenbogen C, Stock KF, Renders L, Heemann U, Roos M. C-terminal agrin fragment (CAF) as a serum biomarker for residual renal function in peritoneal dialysis patients. Int Urol Nephrol. 2015 Feb;47(2):391-6. doi: 10.1007/s11255-014-0852-5. Epub 2014 Oct 29.

  PMID: 25352149 BACKGROUND

• Ojo AO, Wolfe RA, Held PJ, Port FK, Schmouder RL. Delayed graft function: risk factors and implications for renal allograft survival. Transplantation. 1997 Apr 15;63(7):968-74. doi: 10.1097/00007890-199704150-00011.

  PMID: 9112349 BACKGROUND

• Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.

  PMID: 19414839 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, urine

MeSH Terms

Conditions

Delayed Graft Function

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Spyridon Arampatzis, MD

  Dep. of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: January 27, 2015
• Study Start: October 8, 2014
• Primary Completion: September 27, 2018
• Study Completion: September 27, 2018
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

DE (1); CH (1)