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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Ardelyx
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Ardelyx
ClinicalTrials.gov Identifier:
NCT01847092
First received: May 2, 2013
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Type 2 Diabetes Mellitus
Drug: AZD1722
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Ardelyx:

Primary Outcome Measures:
  • Changes in Urine Albumin to Creatinine Ratio (UACR) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PD effect on UACR, eGFR, blood pressure, p-NT-proBNP, s-cardiac troponin, u-aldosterone, p-renin activity, and bioimpedance [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • PD on u-Na excretion, mean weekly stool consistency and stool frequency [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AZD1722
AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks
Drug: AZD1722
Placebo Comparator: Placebo
Placebo capsule BID PO for 12 Weeks
Drug: Placebo
Placebo for AZD1722

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01847092

Contacts
Contact: Susan Edelstein, PhD sedelstein@ardelyx.com
Contact: Lori Marshall, MPH lmarshall@ardelyx.com

Locations
United States, Colorado
Creekside Endocrine Associates PC Recruiting
Denver, Colorado, United States, 80209
Contact: Judith Recht       jrecht47@comcast.net   
Principal Investigator: Leonard Zemel, MD         
Sponsors and Collaborators
Ardelyx
AstraZeneca
  More Information

No publications provided

Responsible Party: Ardelyx
ClinicalTrials.gov Identifier: NCT01847092     History of Changes
Other Study ID Numbers: D5610C00001
Study First Received: May 2, 2013
Last Updated: January 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ardelyx:
albuminuria

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Renal Insufficiency, Chronic
Albuminuria
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Proteinuria
Urination Disorders
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014