Effect of PARP Inhibitors on Glomerular Filtration Rate

NCT04367467 | Terminated

• 1 other identifier: 829785
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor; Ovarian Cancer; Breast Cancer

Keywords

PARPi; Kidney function; Cystatin-C

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

Study Arms (1)

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

Other: Kidney Function Test

Interventions

Kidney Function Test OTHER

Cystatin-C measurement

Individuals with solid tumors receiving PARPi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: NONE RETAINED

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.

MeSH Terms

Conditions

Ovarian Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Payal Shah, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 29, 2020
• Study Start: February 3, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)