Breast Cancer Clinical Trial

Effect of PARP Inhibitors on Glomerular Filtration Rate

Summary

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.

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Full 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

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Breast Cancer

Estimated Enrollment:

2

Study ID:

NCT04367467

Recruitment Status:

Terminated

Sponsor:

University of Pennsylvania

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There is 1 Location for this study

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University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

2

Study ID:

NCT04367467

Recruitment Status:

Terminated

Sponsor:


University of Pennsylvania

How clear is this clinincal trial information?

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