Solid TumorNCT04367467
Effect of PARP Inhibitors on Glomerular Filtration Rate
An observational study of Solid Tumor and Ovarian Cancer, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor, Ovarian Cancer, Breast Cancer
- What is being tested?
- Kidney Function Test
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2020to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients will be recruited from the medical and gynecologic oncology practices at the Abramson Cancer Center / University of Pennsylvania. Patients that are 18+ years or older with a solid organ cancer who are being initiated on PARP inhibitor therapy.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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
- Conditions
- Solid Tumor, Ovarian Cancer, Breast Cancer
- Being tested
- Kidney Function Test
- Keywords
- PARPi, Kidney function, Cystatin-C
- Medical subject headings
- Ovarian Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney Function TestOther
Cystatin-C measurement
| Study group | Role | What they receive |
|---|---|---|
| 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:
* 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 Receives: Other: Kidney Function Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eGFR from Baseline to On-Treatment, 3-9 weeks after PARPi Initiation (Time Point B)
Change in eGFR from baselineto on-treatment by ≥20% as measured using either cystatin C or 24h urine collection
Measured: Study labs will be obtained within 3-9 weeks after PARPi is initiated
Secondary outcomes (1)
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
The percentage of patients who experience a eGFR reduction of ≥30%, and/or
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start3 Feb 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Why it stopped: Due to constraints of COVID19, we were unable to recruit on-site for this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Payal Shah, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367467
- Sponsor's protocol ID
- 829785
- Status last verified
- Jan 2022
- First submitted
- 3 Apr 2020
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PARP Inhibitors on Glomerular Filtration Rate
- ClinicalTrials.gov ID
- NCT04367467
- Acronym / sponsor ID
- 829785
- Conditions
- Solid Tumor, Ovarian Cancer, Breast Cancer
- Keywords
- PARPi, Kidney function, Cystatin-C
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to constraints of COVID19, we were unable to recruit on-site for this study.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with solid tumors receiving PARPi | – | Other: Kidney Function TestKidney 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients will be recruited from the medical and gynecologic oncology practices at the Abramson Cancer Center / University of Pennsylvania. Patients that are 18+ years or older with a solid organ cancer who are being initiated on PARP inhibitor therapy.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kidney Function TestCystatin-C measurement | Other | Individuals with solid tumors receiving PARPi |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Due to constraints of COVID19, we were unable to recruit on-site for this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Payal Shah, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor and Ovarian Cancer, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to constraints of COVID19, we were unable to recruit on-site for this study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.