TRK-100STP Phase IIb/III Clinical Study Protocol?Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)?
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0000507
- Lead Sponsor
- Parexel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 750
Patients who meet all of the following criteria will be enrolled in the study.
[At Pre-Enrollment]
(1)The patient of the legal age (country-specific), and is younger than 76 years old at the time of informed consent.
(2)The patient who has provided written informed consent by him/herself
(3)The CRF patient with primary glomerular disease or nephrosclerosis as the primary disease.
(4)The patient with progressive CRF presenting with a slope of -0.005 dL/mg or less over 4 weeks for the least-squares regression line plotted with at least three 1/SCr data points. These data should include all SCr values measured within 1 year before submission of informed consent. In addition, these data should contain at least one measurement result obtained 6 or more months before the submission of the informed consent.
(5)The patient all of whose SCr measurements used in Inclusion Criteria (4) are greater than 0.5 times and less than 2.0 times the SCr measured at the last point before the date of informed consent.
[At Enrollment to the Treatment period]
(6)The patient whose SCr measurement at the last 2 points during the Run-in period are both within 2.00-4.50 mg/dL.
Patients who meet any of the following criteria will not be enrolled in the study.
[At Pre-Enrollment]
(1)The patient whose glomerular disease is secondary to diabetic nephropathy, lupus nephritis, ANCA-related nephritis, renal amyloidosis, hepatitis virus-associated nephropathy, Wegener’s granulomatosis, purpuric nephritis, hereditary nephritis (Alport’s syndrome), Fabry’s disease, benign familial hematuria (thin glomerular basement membrane syndrome), kidney hypoplasia, etc.
(2)The patient with CRF caused by pyelonephritis, interstitial/tubular nephritis, gouty kidney, polycystic kidney disease, or nephroureterolithiasis.
(3)The patient who has been administered an oral/injectable steroid agent, newly or increased in dose for treatment of a kidney disease during the one year prior to the date of informed consent.
(4)The patient who has taken NSAIDs during the one week prior to the date of informed consent. However, topical medications (other than suppositories), and aspirin medications (up to 324 mg/day) are acceptable.
(5)The patient with diabetes mellitus.
(6)The patient who has a history of undergoing renal transplantation, hemodialysis or peritoneal dialysis within a year prior to the date of informed consent; or the patient who is planned for renal transplantation, hemodialysis, or peritoneal dialysis within 24 weeks following the date of informed consent.
(7)The patient with nephrotic syndrome.
(8)The patient with renal-artery stenosis.
(9)The patient who is bleeding (hemophilia, capillary fragility, gastrointestinal hemorrhage, urinary tract hemorrhage, hemoptysis, fundus oculi hemorrhage), or has a bleeding tendency.
However, transient bleeding (nasal, menstrual, gingival, and hemorrhoidal bleeding, etc.) will not be applied to this criterion.
(10)The patient with malignant hypertension or uncontrolled hypertension (with a sitting systolic blood pressure of 150 mmHg or higher, or a sitting diastolic blood pressure of 95 mmHg or higher, at three latest measurement points before the date of informed consent).
(11)The patient with a history of malignant tumor or the patient’s condition is complicated by malignant tumor. (However, enrollment is possible if the tumor has not relapsed for 5 years or longer.)
(12)The patient with serious hepatic disease, blood dyscrasia, respiratory disease, gastrointestinal disease, heart disorder, cerebellar or cerebral disorders.
(13)The patient with an allergy to BPS.
(14)The patient who has taken BPS during the one year prior to the date of informed consent.
(15)The patient who took TRK-100STP during the Phase II Clinical Trial [Chronic renal failure (primary glomerular disease/nephrosclerosis)].
(16)In Japan: the patient who has been administered other investigational drugs or post-marketing study drugs during the 16 weeks prior to the date of informed consent.
Countries and regions outside of Japan: Comply with the local regulations for the enrollment of patients administered with other investigational drugs or post-marketing study drugs prior to informed consent.
(17)The patient who is pregnant, breastfeeding, or wishes to become pregnant during the clinical trial period.
(18)The patient with a history of drug abuse or alcohol abuse.
(19)The patient who has considerably poor self-management skills (dietary therapy, following drug regimens, etc.)
(20)The patient who was judged to be inappropriate as a subject by the principal investigator or the subinvestigator.
[At Enr
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to first occurrence of Renal composite endpoints
- Secondary Outcome Measures
Name Time Method Renal composite endpoint or death(from any cause);Doubling of SCr;Introduction of dialysis ;Renal transplantation ;Increase in SCr to 6.0 or higher ;Slope of 1/SCr