Clinical trial · Interventional
Pharmacokinetics in Subjects With Renal Impairment
A Phase I, Open-label, Parallel-group, Mono-center Trial to Investigate the Pharmacokinetics of a Single Intravenous Dose of Cilengitide in Subjects With Mild, Moderate or Severe Renal Impairment Compared to Subjects With Normal Renal Function
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, non-randomized, parallel-group, mono-center, single intravenous dose, Phase I trial to investigate the Pharmacokinetic (PK) and safety of cilengitide in subjects with different grades of renal impairment as compared to subjects with normal renal function.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Impairment | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cilengitide 1000mg | Drug | — | UNRESOLVED |
| cilengitide > 1000mg and up to 2000mg | Drug | — | UNRESOLVED |
| cilengitide 2000mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- Healthy volunteers: matched subjects with normal renal function
- interventionNames
- Drug: cilengitide 2000mg
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Mild renal impaired subjects
- interventionNames
- Drug: cilengitide 2000mg
- type
- EXPERIMENTAL
- label
- Group 3
- description
- Moderate renal impaired subjects
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: \- Body mass index (BMI): ≥ 18 kg/m² and ≤ 35 kg/m² For subjects with normal renal function: * Vital signs (pulse rate and blood pressure) within the normal range or showing no clinically relevant deviation * Estimated creatinine clearance according to the MDRD equation of ≥ 90 mL/min at Screening For subjects with impaired renal function: * Laboratory parameters should be within acceptable range for subjects with renal impairment, * Vital signs: Pulse rate within the normal range of 45-100 beats/minute in supine position after 5 minutes of rest. Blood pressure diastolic below 100 mmHg, and systolic below 160 mmHg for Groups 1-3 and below 180 mmHg for Group 4a and 4b, in supine position after 5 minutes of rest * Calculated creatinine clearance according to the MDRD equation of \< 90 mL/min at Screening and the possibility of stratification to one of the Groups. Exclusion Criteria: * History of malignant disease within the last 5 years or acute malignant disease * Medical history of wound healing problems and/or any current open wounds * Current or history of bleeding disorders and/or history of thromboembolic events (considering family history as well); thrombolytics or oral or parenteral anticoagulants within 30 days prior to Day 1 * Electrocardiogram recording (12-lead ECG) with signs of clinically relevant pathology as judged by the Investigator For subjects with impaired renal function: * Chronic heart failure non stabilized (New York Heart Association \[NYHA\] class III and IV) * Acute renal failure of any etiology (including viral, toxic, or drug induced) * Requiring dialysis * History of renal transplantation * Uncontrolled diabetes mellitus as judged by the Investigator
References
Publications (0)
Data not yet available