An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)

NCT02675998 | Completed Phase 3 Results

• 1 other identifier: TEN-02-201
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 32

Brief Summary

This phase 3, 8-week, randomized, double-blind, parallel group, multi-center study with a 4-week, placebo-controlled, randomized withdrawal period will evaluate the efficacy, safety and tolerability of Tenapanor to treat hyperphosphatemia in end-stage renal disease patients on hemodialysis (ESRD-HD). Subjects who qualify are randomized into the study will either receive 3 mg BID, 10 mg BID, or a titration regimen of tenapanor.

Conditions

Hyperphosphatemia

Outcome Measures

Primary Outcomes (1)

• Placebo Adjusted Change in Serum Phosphate During Randomized Withdrawal Period From Pooled Tenapanor Arms

  Serum phosphorus difference between placebo and tenapanor in the change from the end of the 8 week treatment period to the end of the randomized withdrawal period in Efficacy Analysis Set. The efficacy analysis was pre-defined to be a pooled analysis of all tenapanor treated patients with a minimum of a 1.2 mg/dL decrease in serum phosphorus during the 8-week treatment period

  4 weeks

Secondary Outcomes (1)

• Change in Serum Phosphate During 8-Week Treatment Period

  Baseline and 8 weeks

Study Arms (4)

3mg BID

EXPERIMENTAL

Tenapanor, 3mg BID (6mg total)

Drug: Tenapanor

10mg BID

EXPERIMENTAL

Tenapanor, 10mg BID (20mg total)

Drug: Tenapanor

Dose Titration

EXPERIMENTAL

Tenapanor, patients start at 30mg BID and can down titrate weekly to 20, 15, 10, and 3mg BID, sequentially based on a GI tolerability question

Drug: Tenapanor

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Tenapanor DRUG

Also known as: RDX5791, AZD1722

10mg BID; 3mg BID; Dose Titration

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years old
• Females must be non-pregnant, non-lactating, and either be post-menopausal for at least 12 months, have documentation of irreversible surgical sterilization, or confirm the use of one of the acceptable contraceptive methods.
• Males must agree to avoid fathering a child and agree to use an appropriate method of contraception
• Chronic maintenance hemodialysis 3x/week for at least 3 months
• Kt/V ≥ 1.3 at most recent measurement prior to screening
• Prescribed and taking at least 3 doses of phosphate binder per day
• Serum phosphate levels should be between 4.0 and 7.0 mg/dL (inclusive) at screening
• For randomization in the study, after 1 week wash-out of phosphate binders, subjects must have serum phosphate level of at least 9 mg/dL but below 10 mg/dL and have had an increase of at least 1.5 mg/dL versus pre-wash out value
• For randomization in the study, after 2 or 3 weeks wash-out of phosphate binders, subjects must have serum phosphate level of at least 6 mg/dL but below 10 mg/dL and have had an increase of at least 1.5 mg/dL versus pre-wash out value

You may not qualify if:

• Severe hyperphosphatemia defined as \>10 mg/dL on Phosphate-binders at any time point during clinical routine monitoring for the 3 preceding months before screening
• Serum parathyroid hormone \>1200 pg/mL
• Persistent metabolic acidosis defined as serum carbon dioxide \<18 mmol/L from two consecutive measurements during screening and washout periods
• Clinical signs of hypovolemia at randomization
• History of inflammatory bowel disease (IBD) or diarrhea predominant irritable bowel syndrome (IBS-D)
• Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center during the study period
• Diarrhea or loose stools during the week before randomization defined as BSFS ≥ 6 and frequency ≥ 3 for 2 or more days
• Any evidence of or treatment of malignancy within one year, excluding non-melanomatous malignancies of the skin
• Positive serology with evidence of significant hepatic impairment or WBC elevation according to the Investigator
• Life expectancy \< 6 months

Sponsors & Collaborators

• Ardelyx: lead

Study Sites (32)

Ardelyx Investigative Site 429

Huntsville, Alabama, 35805, United States

Location

Ardelyx Investigative Site 425

Riverside, California, 92505, United States

Location

Ardelyx Clinical Site 403

Denver, Colorado, 80230, United States

Location

Ardelyx Investigative Site 410

Lauderdale Lakes, Florida, 33313, United States

Location

Ardelyx Investigative Site 430

Miami, Florida, 33173, United States

Location

Ardelyx Investigative Site 427

Meridian, Idaho, 83642, United States

Location

Ardelyx Investigative Site 432

Shreveport, Louisiana, 71101, United States

Location

Ardelyx Investigative Site 415

Bethesda, Maryland, 20814, United States

Location

Ardelyx Investigative Site 402

Kalamazoo, Michigan, 49008, United States

Location

Ardelyx Investigative Site 424

Roseville, Michigan, 48066, United States

Location

Ardelyx Investigative Site 409

Brookhaven, Mississippi, 39601, United States

Location

Ardelyx Investigative Site 417

Columbus, Mississippi, 39705, United States

Location

Ardelyx Investigative Site 431

Tupelo, Mississippi, 38801, United States

Location

Ardelyx Investigative Site 423

St Louis, Missouri, 63136, United States

Location

Ardelyx Investigative Site 416

Albuquerque, New Mexico, 87109, United States

Location

Ardelyx Investigative Site 419

The Bronx, New York, 10803, United States

Location

Ardelyx Investigative Site 408

Asheville, North Carolina, 28805, United States

Location

Ardelyx Investigative Site 411

Charlotte, North Carolina, 28204, United States

Location

Ardelyx Investigative Site 420

New Bern, North Carolina, 28562, United States

Location

Ardelyx Investigative Site 426

Raleigh, North Carolina, 27609, United States

Location

Ardelyx Investigative Site 412

Wilmington, North Carolina, 28403, United States

Location

Ardelyx Investigative Site 414

Bethlehem, Pennsylvania, 18017, United States

Location

Ardelyx Investigative Site 404

Columbia, South Carolina, 29203, United States

Location

Ardelyx Investigative Site 421

Orangeburg, South Carolina, 29118, United States

Location

Ardelyx Investigative Site 428

Sumter, South Carolina, 29150, United States

Location

Ardelyx Investigative Site 413

Knoxville, Tennessee, 37923, United States

Location

Ardelyx Investigative Site 418

Nashville, Tennessee, 37205, United States

Location

Ardelyx Investigative Site 406

Austin, Texas, 78758, United States

Location

Ardelyx Investigative Site 405

Bellville, Texas, 77418, United States

Location

Ardelyx Investigative Site 422

San Antonio, Texas, 78215, United States

Location

Ardelyx Investigative Site 407

San Antonio, Texas, 78229, United States

Location

Ardelyx Investigative Site 401

St. George, Utah, 84790, United States

Location

Related Publications (2)

• Sprague SM, Weiner DE, Tietjen DP, Pergola PE, Fishbane S, Block GA, Silva AL, Fadem SZ, Lynn RI, Fadda G, Pagliaro L, Zhao S, Edelstein S, Spiegel DM, Rosenbaum DP. Tenapanor as Therapy for Hyperphosphatemia in Maintenance Dialysis Patients: Results from the OPTIMIZE Study. Kidney360. 2024 May 1;5(5):732-742. doi: 10.34067/KID.0000000000000387. Epub 2024 Feb 7.

  PMID: 38323855 DERIVED

• Silva AL, Chertow GM, Hernandez GT, Lynn RI, Tietjen DP, Rosenbaum DP, Yang Y, Edelstein S. Tenapanor Improves Long-Term Control of Hyperphosphatemia in Patients Receiving Maintenance Dialysis: the NORMALIZE Study. Kidney360. 2023 Nov 1;4(11):1580-1589. doi: 10.34067/KID.0000000000000280. Epub 2023 Oct 19.

  PMID: 37853560 DERIVED

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

tenapanor

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Chief Development Officer
• Organization: Ardelyx

drosenbaum@ardelyx.com

6175134929

Study Officials

• David P Rosenbaum, Ph.D.

  Ardelyx, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: February 3, 2016
• First Posted: February 5, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: January 17, 2018
• Last Updated: August 10, 2020
• Results First Posted: August 10, 2020

Record last verified: 2020-08

Locations

US (32)