Tolvaptan for Hyponatremia in Cirrhotic Patients With Ascites

NCT01716611 | Unknown Phase 4 DMC

• 1 other identifier: KUH1010412
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate the efficacy and safety for the management of hyponatremia and ascites in patients with liver cirrhosis.

Conditions

Hyponatremia; Ascites

Keywords

liver cirrhosis; hyponatemia; ascites; vaptans; antidiuretic hormon; arginine vasopressin

Outcome Measures

Primary Outcomes (1)

• the change in the average daily area under the curve (AUC) for the serum sodium concentration from baseline to day 28 after intervention

  baseline and 28 days

Secondary Outcomes (8)

• the change in the average daily area under the curve (AUC) for the serum sodium concentration from baseline to day 4

  baseline and 4 days

• the time to normalization of the serum sodium concentration

  up to 28 days

• the time to first paracentesis, number of paracentesis, the volume of ascitic fluid obtained from paracentesis

  up to 28 days

• Abdominal discomfort based on a 100-mm visual analogue scales (VAS)

  day 1, 2, 3, 4, 7, 14, 21, 28

• The change in the dose of concomitant diuretics from baseline at day 28

  day 1, 2, 3, 4, 7, 14, 21, 28

Study Arms (2)

Tolvaptan group

ACTIVE COMPARATOR

Form : Tablet, Dosage: 15 mg, 30 mg or 60 mg, Frequency: once a day. Duration: 28days

Drug: Tolvaptan

Placebo group

PLACEBO COMPARATOR

Form : Tablet, Dosage: 15 mg, 30 mg or 60 mg, Frequency: once a day. Duration: 28days

Drug: placebo

Interventions

Tolvaptan DRUG

15 - 60 mg/day for 28 days

Also known as: SAMSCA

Tolvaptan group

placebo DRUG

Placebo group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Patients with cirrhosis as diagnosed by liver biopsy or a combination of laboratory (thrombocytopenia), radiologic (cirrhotic feature of liver, splenomegaly, collateral shunt on US, CT, or MRI) and endoscopic findings (gastoesophageal varices or portal hypertensive gastropathy)
• ≥ Grade 2 ascites who have already been treated with restricted salt diet within 3 month
• Hyponatremia (Serum sodium ≥120 mEq/L and ≤130 mEq/L)
• Written informed consent

You may not qualify if:

• Hypovolemic hyponatremia (Patients with hypotension or chronic heart failure)
• Serum potassium concentration \> 5.5 mEq/L
• Serum bilirubin \> 5.0 mg/dL
• Blood coagulation factor \< 40% or international normalized ratio (INR) \> 2.3
• Platelet count \< 30,000/mm3
• Serum creatinine \> 3 mg/dL
• Treatment within 2 weeks with vasopressin anlogues
• Systolic blood pressure \<80 mmHg
• History of gastrointestinalesophageal varix bleeding variceal hemorrhage
• Spontaneous bacterial peritonitis
• Hepatic encephalopathy ≥ grade 3
• History of Hepatocellular carcinoma treatment within 3month or viable tumor Viable hepatocellular carcinoma
• Liver transplant
• Previous treatment with transjugular intrahepatic portosystemic stent shunt (TIPS)
• History of significant cardiac diseases such as recent myocardial infarction or ischemic diseases within 1 year of screening

Sponsors & Collaborators

• Konkuk University Medical Center: lead
• Inje University: collaborator
• Korea University Anam Hospital: collaborator
• Hanyang University: collaborator
• Severance Hospital: collaborator
• Seoul St. Mary's Hospital: collaborator
• Samsung Medical Center: collaborator
• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: collaborator
• Hallym University Medical Center: collaborator
• Inha University Hospital: collaborator
• Soonchunhyang University Hospital: collaborator
• Kyungpook National University Hospital: collaborator
• Incheon St.Mary's Hospital: collaborator
• Chungnam National University: collaborator

Study Sites (1)

Konkuk University Medical Center

Seoul, Seoul, 143-729, South Korea

Location

MeSH Terms

Conditions

Hyponatremia; Ascites; Liver Cirrhosis; Diabetes Insipidus

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Fibrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• June Sung Lee, MD, PhD

  Inje University Ilsan Paik Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Won Hyeok Choe, MD

CONTACT

82-2-2030-7506; 20050101@kuh.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 30, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: October 30, 2012

Record last verified: 2012-10

Locations

KR (1)