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

Ardelyx, Inc.0 sites140 target enrollmentMay 6, 2014

ConditionsChronic kidney disease (CKD) with type 2 diabetes mellitus and albuminuria MedDRA version: 17.0Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857 Therapeutic area: Not possible to specify

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic kidney disease (CKD) with type 2 diabetes mellitus and albuminuria
Sponsor: Ardelyx, Inc.
Enrollment: 140
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 6, 2014

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Ardelyx, Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Males or females aged 18 to 80 years, inclusive.
•2\. Females must be non\-pregnant, non\-lactating and fulfilling one of the following:
•a. Post –menopausal defined as amenorrhoea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle stimulating hormone (FSH) levels in the laboratory defined post\-menopausal range.
•b. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral
•salpingectomy but not tubal ligation.
•c. Use of acceptable contraceptive method: IUD with spermicide, a female condom with spermicide, contraceptive
•sponge with spermicide, an intravaginal system (e.g., NuvaRing®), a diaphragm with spermicide, a cervical cap with spermicide, or oral, implantable, transdermal, or injectable contraceptives; or sexual abstinence.
•3\. Males must agree to avoid fathering a child (or donating sperm), and therefore be either sterile or agree to use, from the time of randomization until 45 days after end of study, one of the following approved methods of contraception: a male condom with spermicide; a sterile sexual partner; use by female sexual partner of an IUD with spermicide, a female condom with spermicide, contraceptive sponge with spermicide, an intravaginal system (e.g., NuvaRing®), a diaphragm with spermicide, a cervical cap with spermicide, or oral, implantable, transdermal, or injectable contraceptives.
•4\. Body mass index between 18 and 45 kg/m2, inclusive.
•5\. Patients must have a history of type 2 diabetes mellitus and must be receiving 1 glucose lowering medication for at least 3 months prior to randomization

Exclusion Criteria

•1\. Urinary albumin: UACR \> 3500 mg/g
•2\. History of a renal transplant
•3\. Blood pressure (BP) of MSSBP \>180 mmHg or a MSDBP of \>120 mmHg on two occasions during screening or run\-in
•4\. History of inflammatory bowel disease (IBD) or diarrhea predominant irritable bowel syndrome (IBS\-D)
•5\. Clinical sign of dehydration during screening or run\-in periods
•6\. Poorly controlled diabetes (fasting s\-glucose \>270 mg/dL) based on results collected at Visit 2 (Day \-7\)
•7\. Acidosis (s\-bicarbonate \< 18 mmol/L) based on results collected at Visit 2 (Day \-7\) and obtained from the central lab for the study
•8\. Hepatic dysfunction (alanine aminotransaminase \[ALT] or aspartate aminotransaminase \[AST]) \>3 times the upper limit of normal based on central laboratory reference ranges) based on results collected at Visit 2 (Day \-7\) and obtained from the central lab for the study
•9\. Any biopsy or imaging verifying intercurrent kidney disease other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis
•10\. Any patient with cardiovascular disease as follows: