This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2500

Inclusion Criteria

1. Male and female subjects aged > 18 years with confirmed diagnosis of ADPKD (during participation in prior tolvaptan trials) who have

- Completed and transferred from the double-blind Trial 156-13-210 (12-month period including post-treatment follow-up, regardless of whether this was on-treatment or off-treatment), or

- Completed Trial 156-08-271 or a prior tolvaptan trial, or

- Interrupted or discontinued treatment in a tolvaptan trial other than Trial 156-13-210. Subjects may be enrolled with the medical monitor approval, and additional close monitoring may be required at the beginning of the trial

- Renal function will be assessed during screening by using historical laboratory values (in the last 3 months) for serum creatinine levels to calculate the estimated glomerular filtration rate (eGFR). The eGFR values will be estimated based on the Chronic Kidney Disease - Epidemiology (CKD-EPI) formula.

2. Estimated glomerular filtration rate > 20 mL/min/1.73 m2 (calculated using the CKD-EPI formula) within 3 months prior to the baseline visit. Subjects who have an eGFR <20 mL/min/1.73 m2 may be permitted to enter the trial with medical monitor and sponsor approval and increased frequency of monitoring to ensure safety of subjects
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1. Women of childbearing potential (WOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of IMP. If employing birth control, 2 of the following precautions must be used: vasectomy of partner, tubal ligation, vaginal diaphragm, intrauterine device, birth control. pill, birth control implant, birth control depot injection, condom, or sponge with spermicide.

2. Women who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP.

3. Need for chronic diuretic use.

4. Hepatic impairment based on liver function abnormalities other than that expected for ADPKD with cystic liver disease during screening based on recent historical laboratory values (in the last 3 months).

5. Subjects with contraindications to required trial assessments (contraindications to optional assessments, eg, MRI are not a limitation).

6. Subjects who, in the opinion of the investigator or medical monitor, have a medical history or medical finding inconsistent with safety or trial compliance. This includes prior evidence of significant hepatic injury deemed to be related to tolvaptan use.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method