Clinical trial · Observational
Effect of PARP Inhibitors on Glomerular Filtration Rate
NCT04367467CI-TRIAL-00056150terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to constraints of COVID19, we were unable to recruit on-site for this study.
Summary
Brief summary (as posted)
The purpose of this study is to observe whether PARP inhibitors have an effect on serum creatinine level, and whether this reflects a change in creatinine secretion or a true change in kidney function.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Kidney Function Test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Individuals with solid tumors receiving PARPi
- description
- Kidney function will be assessed by serum creatinine, serum cystatin C, and urine creatinine clearance calculation for patients who opt-in to 24 hour urine collection. These laboratory measures will be completed by patients at the following time points: * Timepoint A: Baseline (prior to PARP inhibitor initiation, at the time of standard of care clinical testing) * Timepoint B: On-treatment (within 3-9 weeks of PARP inhibitor initiation, at the time of standard of care clinical testing) * Timepoint C: Post-treatment (within 4 weeks of PARP inhibitor discontinuation, only for those patients with clinically significant changes in GFR based on serum creatinine, cystatin C, or 24 hour urinalysis at Timepoint B
- interventionNames
- Other: Kidney Function Test
Primary outcomes (1)
- measure
- Change in eGFR from Baseline to On-Treatment, 3-9 weeks after PARPi Initiation (Time Point B)
- timeFrame
- Study labs will be obtained within 3-9 weeks after PARPi is initiated
- description
- Change in eGFR from baselineto on-treatment by ≥20% as measured using either cystatin C or 24h urine collection
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients age 18 years or older * Diagnosed with any solid organ cancer * Planned to receive a PARP inhibitor (olaparib, niraparib, rucaparib, veliparib, or talazoparib) * Able to consent to study related procedures * If unable to give informed consent, must have healthcare proxy or legally authorized representative * Fluent in conversational English (Informed Consent form currently in English language) Exclusion Criteria: * Patients who will not receive ongoing cancer care at Penn Medicine * Major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation * Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff * Patients on dialysis
References
Publications (0)
Data not yet available
No reference posted for this study.