NCT07806708Not yet recruiting
DKK3 as a Biomarker of Peritoneal Fibrosis in Peritoneal Dialysis Patients
PERIMARK - DKK3 as a Biomarker of Peritoneal Fibrosis in Peritoneal Dialysis Patients: A Prospective, Monocentric, Exploratory Longitudinal Study With Biobanking
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 1 Sept 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Dec 2028
- Lead sponsor
- Universität des Saarlandes
- Diseases
- Chronic kidney disease
- NCT number
- NCT07806708
What you commit to
- Study type: Observational
- Planned participants: 30
- From 1 Sept 2026 to the primary completion date, 1 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active malignancy (except basal cell carcinoma of the skin)
Age
- Age \<18 years
Other
- Lack of capacity to give informed consent
- Pregnancy or breastfeeding
- Active peritonitis at time of inclusion
- Life expectancy \<12 months as assessed by the treating physician
- Severe peritoneal adhesions precluding PD catheter insertion (intraoperative assessment)
Who the study is looking for
- 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 in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Saarland University Medical Center Coordinator of this site? Confirm its status | Homburg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.