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Completed

NCT Number: NCT01847092

A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria

The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.

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Key information

Conditions

Chronic Kidney Disease Albuminuria Chronic Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteinuria Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Type 2 Diabetes Mellitus Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Creekside Endocrine Associates PC

Denver, Colorado, 80209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females aged 18 to 80 years, inclusive.
  • Body mass index between 18 and 45 kg/m2, inclusive.
  • Type 2 diabetes mellitus and receiving ≥1 glucose lowering medication for at least 3 months prior to randomization
  • Stage 3 CKD
  • MSSBP ≥130 mmHg
  • Urinary albumin: mean UACR ≥ 200 mg/g

Exclusion criteria

  • Urinary albumin: UACR > 3500 mg/g
  • History of a renal transplant
  • MSSBP >180 mmHg or a MSDBP of >120 mmHg on two occasions during screening or run-in periods
  • History of inflammatory bowel disease or diarrhea predominant irritable bowel syndrome

Treatment and study plan

AZD1722

Drug

Placebo

Drug

Placebo for AZD1722

Primary outcomes

  1. Changes in Urine Albumin to Creatinine Ratio (UACR)

    Time frame: Week 12

    The difference between tenapanor and placebo in the change in UACR from baseline to the end of 12 weeks of treatment

Secondary outcomes

  1. Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Ardelyx

Industry

Collaborators

  • AstraZeneca

Registry information

Official study title

An Exploratory Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Design Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZD1722 in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 6, 2013
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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