Health Condition 1: N288- Other specified disorders of kidney and ureter
Conditions
Interventions
Intervention1: High water therapy: water intake to achieve target serum osmolality
Control Intervention1: Tolvaptan: Tolvaptan will be started doses of 30 mg and 15 mg in morning and evening respectiv
Sponsors
Post Graduate Institute of Medical Education and Research Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1)Patients with estimated glomerular filtration rate � 60 mL/min/1.73 m2 and TKV � 750ml as measured on CT 2) Patients with estimated GFR of 25 to 60 ml/minute/1.73 m2 3) ADPKD Mayo class 1C, 1D, 1E (as per study definitions given below) with estimated GFR of > 25ml/minute/1.73 m2
Exclusion criteria
Exclusion criteria: 1) Imaging suggestive of atypical ADPKD as per mayo classification (as per study definitions given below). 2) Liver disease other than presence of cystic liver disease consistent with ADPKD 3) Elevation of liver enzymes in the pre randomization period with serum transaminases to � 3 times the upper limit of the normal range, elevations in the total bilirubin to � 2 times the upper limit of the normal range. 4) Patients requiring diuretic therapy 5) Patients with severe cardiopulmonary disease preventing high water intake. 6) Subjects with diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes: Change in total kidney volume (TKV) at one year in Tolvaptan and high water intake therapy groups. Timepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Genetic analysis of patients in the two groups 2) Change in estimated glomerular filtration rate (based on MDRD creatinine equation ) 3) Comparison of average urine osmolality, copeptin levels through one year follow up in the two groups. 4) Comparison of adverse effects of the treatment regime in the two groups.Timepoint: 1 year | — |
Countries
India
Contacts
Public ContactDR SMITA DIVYAVEER
Post Graduate Institute of Medical Education and Research, Chandigarh.
Outcome results
None listed