Study of Phosphate Levels in Patients With Chronic Kidney Disease

NCT00824460 | Completed Phase 2 Results

• 2 other identifiers: PA-CL-03A75610
• Study Type: interventional
• Target: 154
• Locations: 9 countries
• Sites: 60

Brief Summary

The purpose of this study is to investigate the ability of different doses of PA21 to lower serum phosphate levels, in patients with chronic kidney disease on maintenance hemodialysis.

Conditions

Chronic Kidney Disease

Keywords

Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Serum-phosphate Levels at the End of Treatment.

  6 weeks after baseline

Secondary Outcomes (3)

• Change From Baseline in Serum-phosphate Levels at Week 2

  2 weeks after baseline

• Change From Baseline in Serum-phosphate Levels at Week 4

  4 weeks after baseline

• Change From Baseline in Serum-phosphate Levels at Week 5

  5 weeks after baseline

Study Arms (6)

1.25 g PA21

EXPERIMENTAL

Drug: 1.25 g PA21 (250 mg iron)

5.0 g PA21

EXPERIMENTAL

Drug: 5.0 g PA21 (1,000 mg iron)

7.5 g PA21

EXPERIMENTAL

Drug: 7.5 g PA21 (1,500 mg iron)

10.0 g PA21

EXPERIMENTAL

Drug: 10.0 g PA21 (2,000 mg iron)

12.5 g PA21

EXPERIMENTAL

Drug: 12.5 g PA21 (2,500 mg iron)

Sevelamer hydrochloride - active control

EXPERIMENTAL

Drug: Sevelamer hydrochloride

Interventions

1.25 g PA21 (250 mg iron) DRUG

Daily dose of 1.25 g PA21 (1 tablet/day) for 6 weeks. One PA21 tablet will be taken orally with the largest meal of the day.

1.25 g PA21

5.0 g PA21 (1,000 mg iron) DRUG

Daily dose of 5.0 g PA21 (4 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with the largest meal of the day, and one PA21 tablet will be taken orally with each of the two smaller main meals of the day (3 meals per day).

5.0 g PA21

7.5 g PA21 (1,500 mg iron) DRUG

Daily dose of 7.5 g PA21 (6 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with each of the three main meals of the day (3 meals per day).

7.5 g PA21

10.0 g PA21 (2,000 mg iron) DRUG

Daily dose of 10.0 g PA21 (8 tablets/day) for 6 weeks. Four PA21 tablets will be taken orally with the largest meal of the day, and two PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).

10.0 g PA21

12.5 g PA21 (2,500 mg iron) DRUG

Daily dose of 12.5 g PA21 (10 tablets/day) for 6 weeks. Four tablets will be taken orally with the largest meal of the day, and three PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).

12.5 g PA21

Sevelamer hydrochloride DRUG

Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets/day) for 6 weeks. Two Sevelamer tablets will be taken orally with each of the three main meals of the day (3 meals per day).

Sevelamer hydrochloride - active control

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years of age,
• Receiving stable maintenance hemodialysis 3 times a week
• On restricted phosphate diet at screening and throughout study
• Receiving stable dose of phosphate binder for at least 1 month
• Serum phosphate levels \>1.78 mmol/L

You may not qualify if:

• Uncontrolled hyperphosphatemia
• Hypercalcemia at screening or during washout
• Serum calcium \< 1.9 mmol/L (\<7.6 mg/dL)
• Severe hyperparathyroidism (iPTH levels \>600 ng/L)
• Pregnancy or lactation
• Iron deficiency anemia
• History of hemochromatosis or ferritin \>800 mg/L,
• Hepatitis B, hepatitis C or other significant concurrent liver disorders
• Known positivity to HIV
• Use of oral iron preparations 1 month before screening,
• Serious medical condition or uncontrolled systemic disease

Sponsors & Collaborators

• Vifor Pharma: lead

Study Sites (60)

Western Nephrology & Metabolic Disease

Arvada, Colorado, 80002, United States

Location

Complete Renal Care

Denver, Colorado, 80220, United States

Location

Pines Clinical Research

Pembroke Pines, Florida, 33028, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Nephrology Associates

Fresh Meadows, New York, 11365, United States

Location

University Hospitals / Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Southeast Renal Research Institute

Chattanooga, Tennessee, 37404, United States

Location

Nephrology Associates

Nashville, Tennessee, 37205, United States

Location

Southwest Houston Research

Houston, Texas, 77099, United States

Location

MHAT

Gabrovo, 5300, Bulgaria

Location

MHAT Plovdiv

Plovdiv, 4003, Bulgaria

Location

Department of Haemodialysis at MHAT

Rousse, 7002, Bulgaria

Location

5th MHAT Sofia

Sofia, 1233, Bulgaria

Location

SHATCVD - National Cardiology Hospital

Sofia, 1309, Bulgaria

Location

MHAT "Tokuda Hospital Sofia"

Sofia, 1407, Bulgaria

Location

UMHAT "Alexandrovska" Dialysis Clinic

Sofia, 1431, Bulgaria

Location

UMHAT "Sveti Ivan Rilski"

Sofia, 1431, Bulgaria

Location

UMHAT "Sveta Anna"

Sofia, 1784, Bulgaria

Location

MDHAT Department of Haemodialysis and Nephrology

Veliko Tarnovo, 5000, Bulgaria

Location

Opca bonica Bjelovar

Bjelovar, 43000, Croatia

Location

Opca bolnica Karlovac

Karlovac, 47000, Croatia

Location

Opca bolnica

Koprivnica, 48000, Croatia

Location

Klinicka bolnica Osijek

Osijek, 31000, Croatia

Location

Klinicki bolnicki centar Rijeka

Rijeka, 51000, Croatia

Location

Klinicki bolnicki centar Split

Split, 21000, Croatia

Location

Opca bolnica Zadar

Zadar, 23000, Croatia

Location

Klinicka bolnica

Zagreb, 10000, Croatia

Location

Poliklinika Sveti Duh II

Zagreb, 10000, Croatia

Location

Klinicka bolnica Dubrava

Zagreb, 10040, Croatia

Location

Innef a.s. Hemodialyzancni stredisko

Brno, 60200, Czechia

Location

Nemocnice Nove Mesto na Morave

Nove Město Na Morave, 59231, Czechia

Location

Nemocnice s poliklinikou v Novem Jicine

Nový Jičín, 74101, Czechia

Location

Klinika nefrologie VFN

Prague, 2, Czechia

Location

Nephrologische Gemeinschaftspraxis und Dialysezentrum

Dortmund, 44263, Germany

Location

Marienhospital

Herne, 44625, Germany

Location

Niepubliczny Zaklad Opieki Zdrowotnej

Golub-Dobrzyń, 87-400, Poland

Location

Katedra i Klinika Nefrologii

Katowice, 40-027, Poland

Location

NZOZ Dializa

Olkusz, 32-300, Poland

Location

Katedra i Klinika Nefrologii

Poznan, 60-355, Poland

Location

Samodzielny Specjalistyczny

Siedlce, 26, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej

Sieradz, 98-200, Poland

Location

Centrum Dializy i Diagnostyki

Warsaw, 01-809, Poland

Location

Institutul Clinic Fundeni

Bucharest, 022328, Romania

Location

Spitalul Universitar de Urgenta Bucuresti

Bucharest, 050098, Romania

Location

Spitalul Clinic

Lasi, 700503, Romania

Location

SC Renamed Nefrodial SRL

Oradea, 410562, Romania

Location

S.C. Avitum S.R.L

Târgu Mureş, 540136, Romania

Location

GOU VPO Kazan

Kazan', 420064, Russia

Location

GUZ City Clinical Hospital

Moscow, 125284, Russia

Location

MUZ City Clinical Hospital

Novosibirsk, 630120, Russia

Location

Saint-Petersburg CUS City Mariinskaya Hospital

Saint Petersburg, 191104, Russia

Location

Saint-Petersburg GUZ City Clinical Hospital

Saint Petersburg, 195257, Russia

Location

GOU VPO

Saint Petersburg, 195607, Russia

Location

Saint-Petersburg GUZ City Hospital

Saint Petersburg, 196247, Russia

Location

GOU VPO

Saint Petersburg, 197089, Russia

Location

CUS City Hospital

Saint Petersburg, 198205, Russia

Location

MLPU Clinical City Hospital

Smolensk, 214001, Russia

Location

Kantonspital Aarau

Aarau, 5001, Switzerland

Location

Chuv Lausanne

Lausanne, 1011, Switzerland

Location

Universitatsspital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

  PMID: 40576086 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Iron; Sevelamer

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

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Polyamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Medical Information
• Organization: Vifor Pharma

medinfo@viforpharma.com

41 58 851 8222

Study Officials

• Prof. Rudolf P Wutrich, MD

  Unafilliated

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2009
• First Posted: January 16, 2009
• Study Start: December 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: March 1, 2010
• Last Updated: April 1, 2014
• Results First Posted: April 1, 2014

Record last verified: 2014-03

Locations

CZ (4); CH (3); PL (7); US (9); CR (10); BU (10); RU (10); RO (5); DE (2)