Safety & Tolerability Study of CTP-499 in Patients With Moderate Chronic Kidney Disease

NCT01460199 | Completed Phase 1

• 1 other identifier: CP505.1003
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief Summary

This study is being conducted to evaluate the safety and tolerability of treatment with CTP-499 in non-dialysis patients associated with moderate chronic kidney disease.

Conditions

Stage 3 Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Safety measures

  number of adverse events, vital signs, ECGs, clinical laboratory measures and physical exams

  4 weeks

Secondary Outcomes (1)

• Pharmacokinetic Profile

  4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: placebo

CTP-499

EXPERIMENTAL

Drug: CTP-499

Interventions

CTP-499 DRUG

3 X 200 mg tablets (QD for 2 weeks) 3 x 200 mg tablets (BID for 2 weeks)

CTP-499

placebo DRUG

tablets

Placebo

Eligibility Criteria

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

You may qualify if:

• Patient has a diagnosis of chronic kidney disease
• If taking antihypertensive and antidiabetes medications, regimen must be stable for a minimum of 4 weeks
• Patient has systolic blood pressure less than or equal to 160 mm Hg and diastolic blood pressure less than or equal to 95 mm Hg

You may not qualify if:

• Patient has concurrent condition such as uncontrolled inflammatory disease, acute infection or clinically unstable autoimmune, endocrine, neurological, psychiatric, retinal, cardiovascular, bronchopulmonary, hepatic, gastrointestinal or musculoskeletal disorder
• Patient has acute, active and/or current unstable renal impairment disease
• Patient has been hospitalized for acute renal failure in the past year
• Patient has active malignancy or a history of neoplastic disease
• Patient has QTc interval \> 450 milliseconds
• Patient is currently on cytotoxic or other immunosuppressive therapy

Sponsors & Collaborators

• Concert Pharmaceuticals: lead

Study Sites (3)

West Coast Clinical Trials

Costa Mesa, California, United States

Location

Southern California Clinical Research

Garden Grove, California, United States

Location

Orange County Research Center

Tustin, California, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

1-(5-hydroxyhexyl)-3,7-dimethylxanthine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James Shipley, MD

  Concert Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: October 26, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 24, 2013

Record last verified: 2013-05

Locations

US (3)