Peritoneal dialysis (PD) uses the peritoneal membrane as a natural filter to remove waste products from the blood in patients with kidney failure. Over time, the peritoneal membrane can become scarred and less functional - a process called peritoneal fibrosis - which eventually leads to ultrafiltration failure and loss of the PD technique. Currently, there is no reliable early biomarker to detect this process before it causes clinical problems.
PERIMARK is a prospective, single-center, observational study investigating whether DKK3 (Dickkopf-3), a protein involved in fibrosis signaling, can serve as an early biomarker of peritoneal membrane deterioration. DKK3 will be measured in urine, peritoneal dialysate and serum at four time points over 12 months (T0: catheter insertion; T1: 12 weeks; T2: 6 months; T3: 12 months). At each follow-up visit, peritoneal membrane function will be assessed by the Modified Peritoneal Equilibration Test (Modified PET) with 3.86% glucose, measuring the sodium dip (ΔDNa) as a marker of aquaporin-1-mediated water transport and D/P creatinine as a marker of small solute transport.
The primary endpoint is the intraindividual change in DKK3/creatinine ratio in urine, dialysate and serum from baseline to 12 months. Secondary endpoints include the correlation of DKK3 with the sodium dip, longitudinal changes in peritoneal transport parameters, and the exploratory question of whether an early DKK3 rise predicts a later decline in aquaporin-1 function.
The study also includes a biobank of serum, urine, dialysate supernatant and cell pellets for possible future analyses. Target enrollment is 25-30 patients.
Age ≥18 years
End-stage renal disease with decision for peritoneal dialysis
PD catheter insertion at Department of Internal Medicine IV, Saarland University Medical Center
Written informed consent obtained at least 24 hours before the first study procedure
Age <18 years
Lack of capacity to give informed consent
Pregnancy or breastfeeding
Active malignancy (except basal cell carcinoma of the skin)
Consecutive adult patients with end-stage renal disease undergoing PD catheter insertion at the Department of Internal Medicine IV, Saarland University Medical Center, Homburg, Germany.
Cohort
Retrospective
Modified Peritoneal Equilibration Test and DKK3 Biomarker Measurement
Diagnostic testModified Peritoneal Equilibration Test (Modified PET) performed with 2L of 3.86% glucose solution according to La Milia et al. (Kidney Int 2006; DOI: 10.1038/sj.ki.5000183). Parameters assessed: sodium dip (ΔDNa at 60 min) as aquaporin-1 marker, D/P creatinine at 240 min for transporter classification, and net ultrafiltration by weighing. Concurrent blood, urine and peritoneal dialysate sampling for DKK3 measurement (Human DKK3 DuoSet ELISA, R\&D Systems) and biobanking. No drug or therapeutic agent is administered.
Change in DKK3/Creatinine Ratio in Urine, Dialysate and Serum
Intraindividual change in DKK3/creatinine ratio in urine, peritoneal dialysate and serum from baseline (T0) to 12 months (T3). Measured by DKK3 ReFine ELISA (DiaRen).
Change in D/P Creatinine
Longitudinal change in dialysate-to-plasma creatinine ratio (D/P creatinine) at 240 minutes in Modified PET from T1 to T3.
Correlation of DKK3 with Sodium Dip (ΔDNa)
Spearman correlation between DKK3/creatinine ratio in dialysate and sodium dip (ΔDNa) in Modified PET at T1, T2 and T3.
Net Ultrafiltration and Ultrafiltration Failure
Net ultrafiltration (ml) after 4-hour dwell with 3.86% glucose solution. Incidence of ultrafiltration failure defined as net UF \<400 ml.
Change in Residual Renal Function
Change in 24-hour urine volume and eGFR (CKD-EPI) from baseline to 12 months.
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