A Phase 3b, Multi-center, Open-label Trial to Evaluate th... | EligiMed

A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/Day, Split Dose) in Subjects With Autosomal Dominant Polycystic Kidney Disease

CompletadoFase 3ClinicalTrials.gov

ID: NCT02251275RENIS: IS001162Tipo: INTERVENTIONALInicio: 17 de oct de 2014Fin estimado: 9 de nov de 2018

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Resumen

The purpose of the trial was to evaluate and describe the long term safety of tolvaptan in participants with autosomal dominant polycystic kidney disease (ADPKD).

Descripción detallada

This was a Phase 3b trial to evaluate and describe the long term safety of tolvaptan treatment in ADPKD participants with chronic kidney disease (CKD). Eligible participants could enroll into Trial 156-13-211 after completing the follow-up visit(s) of their previous trial (156-13-210, 156-08-271, 156-04-251, or 156-09-290). Renal function was assessed during screening by using historical laboratory values for serum creatinine levels to calculate the estimated glomerular filtration rate (eGFR).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male and female participants ≥ 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 prior tolvaptan ADPKD trial other than Trial 156-13-210. Participants may be enrolled with the medical monitor approval, and additional close monitoring may be required at the beginning of the trial.
eGFR ≥ 20 milliliter (mL)/minute (min)/1.73 meter squared (m\^2) within 3 months prior to the baseline visit. Participants who have an eGFR ≤ 20 mL/min/1.73 m\^2 may be enrolled with medical monitor approval.

Criterios de exclusión

Need for chronic diuretic use
Hepatic impairment based on liver function abnormalities other than that expected for ADPKD with cystic liver disease
Women of childbearing potential 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 investigational medicinal product (IMP)
Women who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP.
Participants with contraindications to required trial assessments (contraindications to optional assessments, for example, magnetic resonance imaging \[MRI\] are not a limitation).
Participants who in the opinion of the investigator or the medical monitor, have a medical history or medical finding inconsistent with safety or trial compliance

Intervenciones

drug

Tolvaptan

Tolvaptan tablets (15 or 30 mg) self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later

Ubicaciones

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Junín, Buenos Aires, Argentina

Pergamino, Buenos Aires, Argentina

Pilar, Buenos Aires, Argentina

Córdoba, Argentina

Patrocinadores

PrincipalOtsuka Pharmaceutical Development & Commercialization, Inc.

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