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Search Results Within Category "Kidney & Urinary System"

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7 Study Matches

PSCI 22-124 MAIN-CAV: PHASE III RANDOMIZED TRIAL OF MAINTENANCE CABOZANTINIB AND AVELUMAB VS MAINTENANCE AVELUMAB AFTER FIRST-LINE PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH METASTATIC UROTHELIAL CANCER

To evaluate the effect of cabozantinib in combination with avelumab on OS compared to avelumab alone in patients with mUC who did not progress during first-line platinum-based chemotherapy therapy, i.e. patients who had CR, PR or SD after completion of first line platinum-based chemotherapy.

Patients will be expected to come to all clinic appointments, have labs drawn on the first day of every cycle, take medications as prescribed, return all empty pill bottles and diary, and call the clinic with questions.

Yes
 

Monika Joshi
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05092958
SITE00001285
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Inclusion Criteria:
Histologically or cytologically-confirmed diagnosis of advanced or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra
Prior first-line treatment must have consisted of 4-6 cycles of 1st-line therapy (platinum-based chemotherapy; gemcitabine-cisplatin, gemcitabine-carboplatin, MVAC or ddMVAC).
No prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PDL2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
ECOG Performance Status of 0 or 1
Age ≥ 18 years

Exclusion Criteria:
Active autoimmune disease that might deteriorate when receiving the anti PD-L1 agent, avelumab.
No known symptomatic central nervous system (CNS) metastases.
No major surgery within 4 weeks prior to randomization.
No palliative radiotherapy within 48 hours prior to patient randomization.
No known cavitating pulmonary lesion(s) or known endobronchial disease manifestation.
Kidney & Urinary System, Cancer
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Hershey, PA ,

A Phase III, Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous Nephropathy

To evaluate the effectiveness and safety of obinutuzumab compared to tacrolimus in patients with primary membranous nephropathy

Agree to participate in one of two treatment groups, attend scheduled study visits and have blood drawn for samples. will have visits approximately every 2 to 14 weeks during the first two years of the study, every 12-16 weeks in the third and fourth years of the study, and then every 26 weeks until you finish the study. Visits will usually last 1-3 hours, but visits that require an obinutuzumab infusion may last 6 hours.Your total time in the study will be a minimum of about 4 years, but could be up to about 9 years, depending on how the treatment affects your disease.

$100.00 per visit

Yes
 

Umar Farooq
Kim Hitz - at khitz1@pennstatehealth.psu.edu or 717-531-4924
Medicine: Nephrology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04629248
STUDY00016316
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Inclusion Criteria:
diagnosis of primary membranous nephropathy
age 18-75
ability to comply with requried study procedures
stable blood pressure

Exclusion Criteria:
secondary cause of membranous nephropathy
uncontrolled blood pressure
kidney transplant or dialysis
Type 1 or type 2 diabetes
Kidney & Urinary System
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Hershey, PA ,

A Phase 3 RandOmized Study Comparing PERioperative Nivolumab Vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC) (EA8143) (PSCI 18-025)

Site For 18-025, EA8143 A Phase 3 Study Comparing Perioperative Nivolumab Vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy

You are being asked to take part in this research study because you have cancer in your kidney, which is planned to be removed by a surgeon. The standard treatment for your disease is to remove the kidney or part of the kidney that contains the cancer by surgery. You are then monitored after surgery with imaging scans and exams to watch for any possiblesigns of recurrence (close observation)

Yes
 

Monika Joshi
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03055013
SITE00000234
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Inclusion Criteria:
Newly Diagnosed higher risk RCC of any histology
No clinical or radiological evidence of distant metastases
No concurrent or prior systemic or local anti-cancer therapy for RCC is permitted
Age must be greater than or equal to 18 years old
ECOG Performance status must be 0 or 1

Exclusion Criteria:
Women must not be pregant or breast feeding
History of RCC that was resected with curative intent within the past 5 years
Prior or current prostate cancer is excluded
Active known or suspected autoimmune disease
Uncontrolled adrenal insufficiency
Kidney & Urinary System, Cancer
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Hershey, PA ,

Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer

Upper tract urothelial cancer (UTUC) is a recurrent disease. The current standard treatment for most UTUC patients requires surgery either removing some of the ureter in each operation or radical nephroureterectomy (RNU-removal of kidney and ureter) but the role of minimally invasive & kidney- preserving methods is increasing. The use of TOOKAD (padeliporfin) was investigated in a Phase 1 clinical study in the minimally-invasive treatment of UTUC with the goal of identifying safe laser/light exposure and signs that the tumor has been reduced or eliminated. Early results from this study have been highly promising, revealing the effects of tumor removal with a positive safety profile, indicating the potential role of TOOKAD (padeliporfin) in the treatment of low-grade UTUC disease.This Phase 3 study is designed to provide confirmation of the observed Phase 1 findings. Patients are expected to remain in the study for 25 to 28 months. Participation in this study will include up to 9 study visits to Hershey Medical Center and 2 phone visits.

Yes
 

Jay Raman
Kathleen Lehman - at KLehman3@pennstatehealth.psu.edu or 717-531-5930
Urology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04620239
SITE00000972
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Inclusion Criteria:
New or recurrent low-grade, non-invasive UTUC disease
Biopsy-proven disease. A concurrence of the central pathology reader will be required for eligibility.
Up to 2 biopsy-proven sites of low-grade involvement. Please contact site for tumor dimension criteria.
Karnofsky Performance Status ≥ 50%
Adequate organ function defined by baseline Lab testing

Exclusion Criteria:
Current high-grade or muscle invasive (>pT1) urothelial carcinoma of the bladder
Carcinoma in situ (CIS) current or previous in the upper urinary tract
History of invasive T2 or higher urothelial cancer in past 2 years
Participation in another clinical study involving an investigational product within 1 month before study entry
BCG or local chemotherapy treatment in the upper urinary tract within 2 months prior to inclusion
Kidney & Urinary System, Cancer
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Hershey, PA ,

A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) in subjects with IgA nephropathy

This study will evaluate the safety and effectiveness of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.

Participation for 27 weeks. visits weekly to receive study medication until week 23, visits every 4 weeks to also include blood and urine collection.

up to $100.00 per visit

Yes
 

Umar Farooq
Kim Hitz - at khitz1@pennstatehealth.psu.edu or 717-531-4924
Medicine: Nephrology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04905212
SITE00000982
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Inclusion Criteria:
diagnosis of IgA nephropathy confirmed by biopsy
≥ 18 years old and ≤ 70 years old
Able and willing to complete all study visits and tests
Woman of childbearing potential agreeable to use an effective form of birth control

Exclusion Criteria:
History of kidney or other organ transplant
received systemic glucocorticoids or immunosuppressive therapy in previous 3 months
previous or current diagnosis of active tuberculosis
malignant tumor within 10 years
Kidney & Urinary System
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Hershey, PA ,

A Phase 2a Randomized Placebo-Controlled Double-Blind Multicenter Trial of VIB4920 for Active Lupus Nephritis

A randomized placebo-controlled study to evaluate the efficacy and safety of VIB4920 in study participants with active lupus nephritis

Patients come for in-person visits at the Penn State Hershey main hospital location. There will be blood draws, physical exams, and questionnaires spread out across 60 weeks.

Yes
 

Nancy Olsen
Peri Newman - at pnewman@pennstatehealth.psu.edu or 717-531-0003, ext=287327
Medicine: Rheumatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05201469
SITE00001277
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Inclusion Criteria:
Lupus nephritis
Systemic lupus erythematosus

Exclusion Criteria:
Pregnant
Transplant
Kidney & Urinary System, Arthritis & Rheumatic Diseases, Muscle & Bone
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

PSCI 23-020: EA8212 A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)

If you decide to take part in this study, you will either get Gemcitabine and Docetaxel instilled through a catheter weekly in your bladder for up to 6 weeks, or you will get BCG instilled weekly in your bladder for up to 6 weeks. Your initial therapy may be followed with maintenance therapy.

If you decide to take part in this study, you will either get Gemcitabine and Docetaxel instilled through a catheter weekly in your bladder for up to 6 weeks, or you will get BCG instilled weekly in your bladder for up to 6 weeks. Your initial therapy may be followed with maintenance therapy.After you finish your treatment, your doctor will continue to follow your condition for 5 years with a combination of cystoscopies (inserting a telescope in your bladder) and CT scans (to take images of your body) in order to detect cancer recurrence.

Yes
 

Matthew Kaag
PSCI CTO Office at psci-cto@pennstatehealth.psu.edu or 717-531-5471
Urology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT05538663
SITE00001374
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Inclusion Criteria:
Patient must be > 18 years of age.
Patient must have histologically confirmed high-grade non-muscle invasive urothelial carcinoma of the bladder (HgTa, HGT1, CIS, HgTa + CIS, or HGT1 + CIS stage)
Patient must have ECOG Performance Status 0-2.
Patient must have all visible papillary tumor resected by the treating urologist at the site registering the patient to this protocol prior to randomization.
Patient may have received prior systemic gemcitabine or docetaxel use if it was for a non-bladder malignancy

Exclusion Criteria:
Patients must not have prostatic urethral involvement
Patient must have not received prior intravesical therapy for bladder cancer, with the exception of perioperative chemotherapy at the time of TURBT.
Patient must not have pure squamous cell carcinoma or adenocarcinoma.
Patient must not have any component of neuroendocrine carcinoma (i.e., small cell or large cell).
Patient must not have any component of sarcomatoid, micropapillary, or plasmacytoid variant histology.
Kidney & Urinary System
Experimental drug compared to an approved drug
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Hershey, PA ,