The DIPAK Observational Cohort Study: a multi-center, longitudinal, observational study to investigate renal disease progression and association of disease biomarkers with renal disease progression and ADPKD-related outcomes.
- Conditions
- Autosomal Dominant Polycystic Kidney Diseaseor polycystic kidney disease1003836010029149
- Registration Number
- NL-OMON47875
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 750
1. Diagnosis of ADPKD, based upon the modified Ravine criteria or documented by
treating
nephrologist or internist.
2. Age 18 years and older.
3. Providing informed consent.
• Patients, who are unlikely to adequately comply with the trial*s procedures
(due for instance to medical condition likely to require an extended
interruption or discontinuation)
• Patients taking medications or having concomitant illnesses that are likely
to influence the natural course of ADPKD (e.g. nephrotoxic medications such as
chronic NSAID, cyclosporine, lithium and immunosuppressant use, and e.g.
diabetes mellitus and patients with proteinuria > 1 g/24hr).
• Patients, who receive renal function replacement therapy
• Pregnancy at moment of inclusion
• Patients with a life expectancy less than 1 year at moment of inclusion
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To investigate disease progression factors and association of disease<br /><br>biomarkers with the onset and severity of ADPKD-related outcomes like<br /><br>hypertension, renal function, renal pain renal, albuminuria, renal urine<br /><br>concentrating ability, hematuria, cyst infection, nephrolithiasis and others.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To summarize the levels of self-estimated health status, pain, QoL,<br /><br>ADPKD-related health burden, health care resource use.</p><br>