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HALT Progression of Polycystic Kidney Disease (HALT PKD) Study B (HALT-PKD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Boehringer Ingelheim
Merck Sharp & Dohme Corp.
Polycystic Kidney Disease Foundation
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT01885559
First received: June 17, 2013
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical trials targeting different levels of kidney function: 1) early disease defined by GFR >60 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the first three years. Participants enrolled in Study B will be followed for five-to-eight years, with the average length of follow-up being six and a half years.


Condition Intervention Phase
Kidney, Polycystic
Drug: Lisinopril and Placebo
Drug: Lisinopril and Telmisartan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Polycystic Kidney Disease-Treatment Network

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Time to 50% reduction of baseline eGFR, ESRD (initiation of dialysis or preemptive transplant), or death. [ Time Frame: Patients followed for 5-8 years with average of 6.5 years follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Albuminuria [ Time Frame: up to 8 years (annually assessed) ] [ Designated as safety issue: No ]
  • Aldosterone [ Time Frame: up at 8 years (annually assessed) ] [ Designated as safety issue: No ]
  • Hospitalizations [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
  • Cardiovascular Hospitalizations [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
  • Quality of Life Physical Component [ Time Frame: up to 8 years (annually assessed) ] [ Designated as safety issue: No ]
  • Quality of Life Mental Component Summary [ Time Frame: up to 8 years (annually assessed) ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: up to 8 years (annually assessed) ] [ Designated as safety issue: No ]

Enrollment: 486
Study Start Date: January 2006
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: ACE-I + placebo
ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg
Drug: Lisinopril and Placebo
Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.
Other Names:
  • ACE-I
  • ACE
  • Ace-Inhibitor
  • Lisinopril
  • ARB
  • Placebo
Active Comparator: ACE-I + ARB
ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg
Drug: Lisinopril and Telmisartan
Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.
Other Names:
  • ACE-I
  • ACE
  • Ace-Inhibitor
  • Lisinopril
  • ARB
  • Telmisartan

Detailed Description:

* Specific Aim of Study B

To study the effects of ACE-I/ARB combination therapy as compared to ACE-I monotherapy in the setting of standard blood pressure control (110-130/80 mm Hg) on the time to a 50% reduction of baseline eGFR, ESRD or death, in hypertensive individuals with moderate renal insufficiency (GFR 25-60 mL/min/1.73m2).

* Hypothesis to be tested in Study B

In hypertensive ADPKD individuals with moderate renal insufficiency (GFR 25-60 mL/min/1.73 m2), intensive blockade of the RAAS using combination ACE-I/ARB therapy will slow the decline in kidney function over ACE-I monotherapy, independent of standard blood pressure control (110-130/80 mm Hg).

  Eligibility

Ages Eligible for Study:   15 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of ADPKD.
  • Age 15-49 (Study A); Age 18-64 (Study B).
  • GFR >60 mL/min/1.73 m2 (Study A); GFR 25-60 mL/min/1.73 m2 (Study B).
  • BP ≥130/80 or receiving treatment for hypertension.
  • Informed Consent.

Exclusion Criteria:

  • Pregnant/intention to become pregnant in 4-6 yrs.
  • Documented renal vascular disease.
  • Spot urine albumin-to-creatinine ratio of >0.5 (Study A) or ≥1.0 (Study B) and/or findings suggestive of kidney disease other than ADPKD.
  • Diabetes requiring insulin or oral hypoglycemic agents / fasting serum glucose of >126 mg/dl / random non-fasting glucose of >200 mg/dl.
  • Serum potassium >5.5 mEq/L for participants currently on ACE-I or ARB; >5.0 mEq/L for participants not currently on ACE-I or ARB.
  • History of angioneurotic edema or other absolute contraindication for ACE-I or ARB. Intolerable cough associated with ACE-I is defined as a cough developing within six months of initiation of ACE-I in the absence of other causes and resolving upon discontinuation of the ACE-I.
  • Indication (other than hypertension) for β-blocker or calcium channel blocker therapy (e.g. angina, past myocardial infarction, arrhythmia), unless approved by the site principal investigator. (PI may choose to accept an individual who is on only a small dose of one of these agents and would otherwise be eligible.)
  • Systemic illness necessitating NSAIDs, immunosuppressant or immunomodulatory medications.
  • Systemic illness with renal involvement.
  • Hospitalized for acute illness in past 2 months.
  • Life expectancy <2 years.
  • History of non-compliance.
  • Unclipped cerebral aneurysm >7mm diameter.
  • Creatine supplements within 3 months of screening visit.
  • Congenital absence of a kidney (also total nephrectomy for Study B).
  • Known allergy to sorbitol or sodium polystyrene sulfonate.
  • Exclusions specific to MR imaging (Study A).
  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: NCT01885559

Locations
United States, Colorado
University of Colorado Health Sciences Center
Denver (Aurora), Colorado, United States, 800045
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Tufts University-New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Boehringer Ingelheim
Merck Sharp & Dohme Corp.
Polycystic Kidney Disease Foundation
Investigators
Study Chair: Robert Schrier, M.D. University of Colorado, Denver
Principal Investigator: Arlene Chapman, M.D. Emory University
Principal Investigator: Ronald Perrone, M.D. Tufts University-New England Medical Center
Principal Investigator: Vicente Torres, M.D. Mayo Clinic
Study Director: Marva Moxey-Mims, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Charity G Moore, PhD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT01885559     History of Changes
Other Study ID Numbers: DK62401-PKD-TN (IND)
Study First Received: June 17, 2013
Last Updated: June 20, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
pkd
polycystic kidney disease
polycystic
kidney
disease
adpkd
halt
blood pressure
bp
hypertension
renal
renin-angiotensin-aldosterone-system
RAAS

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Urologic Diseases
Kidney Diseases, Cystic
Angiotensin-Converting Enzyme Inhibitors
Lisinopril
Telmisartan
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 26, 2014