Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease

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Brief Title

Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease

Official Title

Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease

Brief Summary

      To evaluate the safety and therapeutic effectiveness of tolvaptan when administered to slow
      the progression of cyst development and renal function insufficiency in adult Korean patients
      diagnosed with rapidly progressive ADPKD who have chronic kidney disease (CKD) stages 1-3 at
      initiation of treatment.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

The incidences of TEAEs

Secondary Outcome

 Total kidney volume (TKV) annual mean percent change rate [%/year]

Condition

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Intervention

Tolvaptan

Study Arms / Comparison Groups

 tolvaptan
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

118

Start Date

July 1, 2019

Completion Date

June 30, 2022

Primary Completion Date

June 30, 2022

Eligibility Criteria

        Inclusion Criteria:

          1. Subjects who voluntarily participate by giving written informed consent on this trial

          2. Male and female patients aged ≥ 19 to ≤ 50 years

          3. Subjects diagnosed with ADPKD based on the Unified Criteria for Ultrasonographic
             diagnosis of ADPKD (Pei-Ravine Criteria)

          4. Subjects with confirmed CKD stages 1-3 at the screening visit

          5. Subjects with confirmed rapidly progressive typical ADPKD 'Typical ADPKD'

               -  refers to bilateral and diffuse distribution, with mild, moderate or severe
                  replacement of kidney tissue by cysts, where all cysts contribute similarly to
                  TKV.

        'rapidly progressive ADPKD'

          -  Patients will be defined as 'rapidly progressive ADPKD' if they meet any of the
             following criteria:

               -  Mayo class 1C, 1D or 1E

                    -  Truncating PKD1 mutation confirmed by genetic testing before participating
                       this trial ③ PRO-PKD score > 6 ④ Patients with ADPKD with a decline in
                       Estimated glomerular filtration rate(eGFR) ≥ 5 mL/min/1.73 m2 within 1 year
                       from the screening visit or with an average annual decline in eGFR ≥ 2.5
                       mL/min/1.73 m2 over a period of 5 years (excluding patients with an eGFR
                       decline due to factors other than ADPKD, such as uncontrolled type 2
                       diabetes, early diabetic glomerular disease or immune-mediated
                       glomerulonephritis)

        Exclusion Criteria:

          1. Patients with hyponatremia or hypernatremia

          2. Patients with anuria

          3. Patients with volume depletion

          4. Patients who are unable to sense or appropriately respond to thirst

          5. Patients with contraindications to MRI assessment [e.g., ferromagnetic metal
             prosthesis, aneurysm clips, severe claustrophobia, large tattoo on the abdomen or
             back, etc.]

          6. Patients with severe renal impairment [e.g., patients with currently active
             glomerulonephritis, kidney cancer, having a single kidney, history of renal surgery
             within the last 3 years, etc.]

          7. Patients with severe hepatic impairment [e.g., cirrhosis, viral hepatitis, unspecified
             liver function test abnormalities (ALT or Aspartate aminotransferase(AST)) > 3 x ULN
             or Total Bilirubin > 2 x ULN), etc.]

          8. Patients with eGFR decline due to factors other than ADPKD (e.g., uncontrolled type 2
             diabetes, early diabetic glomerular disease or immune-mediated glomerulonephritis,
             etc.)

          9. Patients with a history of hypersensitivity and/or specific reactions to benzazepine
             or benzazepine derivatives (such as Benazepril), or tolvaptan

         10. Patients with hereditary problems of galactose intolerance, the Lapp lactose
             deficiency or glucose-galactose malabsorption, etc.

         11. Patients who need chronic diuretic use

         12. Patients who are receiving any experimental (not marketed) or approved therapies that
             may affect the treatment of ADPKD within 6 months from the screening visit [e.g.,
             anti-sense RNA therapy, rapamycin, sirolimus, everolimus and somatostatin analogs
             (octreotide, sandostatin), vasopressin antagonist (mozavaptan, conivaptan),
             vasopressin agonist (desmopressin)]

         13. Patients who have received cyst decompression or sclerotherapy within 3 years from the
             screening visit

         14. Patients with a history of taking tolvaptan within 6 months from the screening visit

         15. Patients who received any investigational medicinal product in another trial within 30
             days from the screening visit

         16. Fertile women who are currently pregnant or breat feeding, or not willing to use or
             capable of using acceptable contraceptive methods (abstinence, oral, implanted or
             injected hormonal methods of contraception, intrauterine device or barrier methods of
             contraception, such as condom, contraceptive diaphragm and spermicidal agents) to
             avoid pregnancy until completion of the trial

         17. Patients who are, in the opinion of the investigator, unable to comply with the
             administration of the Investigational Medicinal Product(IMP) or the trial procedures
      

Gender

All

Ages

19 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT03949894

Organization ID

156-402-00144


Responsible Party

Sponsor

Study Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.


Study Sponsor

, , 


Verification Date

September 2020