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Prognostic evaluation with focus on renal function of molecular target drugs for Unresectable or Metastatic Renal Cell Carcinoma patients with Renal Dysfunction

Prognostic evaluation with focus on renal function of molecular target drugs for Unresectable or Metastatic Renal Cell Carcinoma patients with Renal Dysfunction - Prognostic evaluation with focus on renal function of molecular target drugs for Unresectable or Metastatic Renal Cell Carcinoma patients with Renal Dysfunction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021981
Enrollment
30
Registered
2016-04-19
Start date
2015-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal cell carcinoma

Interventions

Administration of sorafenib

Sponsors

Shinshu University school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Histologically proven Renal cell carcinoma (2)Over 20yrs (3)PS:0-1(ECOG grade) (4)eGFR<90ml/min(including dialysis patients) (5)Surgically unresectable (6)Life Expectancy must be >=6 months (7)Adequate hematologic, hepatic and respiratory function (8)Interval of at least 2 weeks between prior treatment and start of present study (9)Written informed consent

Exclusion criteria

Exclusion criteria: (1)Presence or past history of interstitial pneumonia or pulmonary fibrosis or possible (2)Active infections(excluding viral hepatitis) (3)Severe cardiac disorder, renal disorder, liver disorder, ulcer with bleeding, intestinal tract paralysis, uncontrollable diabetes mellitus (4)Presence of pleural effusion or ascites requiring drainage (5)Presence of metastasis in central nerve system (6)Active double cancer except carcinoma in situ or intramucosal cancer(synchronous double or asynchronous double cancer with disease free duration to be within 3 years) (7)Pregnant females or nursing mothers who can not stop lactation.Patients or partners, who do not attempt to doing contraception during the study period. (8)Severe mental disorder (9)Severe drug hypersensitivity (10)As determined by the principal investigator or the sub-investigator the subject is not adequate to participate in the trial.

Design outcomes

Primary

MeasureTime frame
eGFR(every 4 weeks)

Secondary

MeasureTime frame
overall Survival Progression Free Survival(PFS) Response Rate(CR+PR) Safety To confirm the molecular target drug usage before and after

Countries

Japan

Contacts

Public ContactToshiro Suzuki

Shinshu University school of medicine Department of Urology

yokoso1046@shinshu-u.ac.jp+81263372661

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026