- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04367467
Effect of PARP Inhibitors on Glomerular Filtration Rate
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PARPi medications interact with transporters along the renal tubules involved in the secretion of creatinine and an increase in serum creatinine is often observed in patients treated with these agents; however, it is not known whether PARP inhibitors are associated with an actual change in the glomerular filtration rate, or if the observed elevations of serum creatinine are a result of a drug effect on creatinine secretion unrelated to changes in kidney function. The investigators therefore propose a prospective observational study to examine the incidence of elevation in serum creatinine from baseline levels in patients initiated on PARP inhibitors and compare the estimated glomerular filtration rate based on creatinine to that from alternative tests.
The primary purposes of this study are to:
- Assess the incidence of increase in serum creatinine in patients with a solid-organ cancer on treatment with a PARP inhibitor.
- To compare the estimated glomerular filtration rate based on serum creatinine with that of alternative biomarkers to assess whether changes in serum creatinine reflect changes in kidney function or creatinine secretion.
- To examine the persistence or resolution of creatinine increase and/or GFR decrease noted after discontinuation of PARPi
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Individuals with solid tumors receiving PARPi
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:
|
Cystatin-C measurement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in eGFR from Baseline to On-Treatment, 3-9 weeks after PARPi Initiation (Time Point B)
Time Frame: Study labs will be obtained within 3-9 weeks after PARPi is initiated
|
Change in eGFR from baselineto on-treatment by ≥20% as measured using either cystatin C or 24h urine collection
|
Study labs will be obtained within 3-9 weeks after PARPi is initiated
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Within 4 Weeks of Post-discontinuation of PARPi (Time Point C) for patients with clinically significant changes in eGFR based on serum creatinine, cystatin C, or 24 hour urinalysis at Timepoint B
Time Frame: 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
|
The percentage of patients who experience a eGFR reduction of ≥30%, and/or
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Payal Shah, MD, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 829785
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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