Renal Effects of an Angiotensin Converting Enzyme Inhibitor in Adults With Chronic Kidney Disease of Uncertain Aetiology

NCT01624064 | Unknown Phase 1 DMC

• 1 other identifier: NSF CKDu Research
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Enalapril would significantly reduce progression of renal disease in patients with Chronic Kidney Disease of Uncertain aetiology.

Conditions

Renal Insufficiency, Chronic

Keywords

Renal Insufficiency, Chronic; Uncertain aetiology; ACEI

Outcome Measures

Primary Outcomes (2)

• Proteinuria

  Numerous clinical trials have established that angiotensin-converting enzyme inhibitors (ACEI) are beneficial in slowing progression of renal disease. However the long-term renal effect of these agents in early renal disease is not well demonstrated. In fact the trials which showed benefits with ACEI did show in glomerular disease and evidence is not so strong in tubulo-interstitial disease.

  One year

• Estimated GFR

  In most forms of proteinuric chronic renal disease, glomerular filtration rate continues to decline even when the initial insult has been removed. The cause of CKDu is still unknown. CKDu is a tubulo-interstitial disease with low grade proteinuria. We believe that the place of ACEI for secondary prevention of CKDu progression needs investigation.

  One year

Secondary Outcomes (2)

• All cause mortality

  One year

• Cardiovascular mortality

  One year

Study Arms (4)

Enalapril, Proteinuria < 1g/day

ACTIVE COMPARATOR

Drug: Enalapril

Calcium, Proteinuria < 1g/day

PLACEBO COMPARATOR

Drug: Calcium Supplement

Enalapril, Proteinuria > 1g/day

ACTIVE COMPARATOR

Drug: Enalapril

Calcium, Proteinuria > 1g/day

PLACEBO COMPARATOR

Drug: Calcium Supplement

Interventions

Enalapril DRUG

2.5-20 mg/day

Also known as: Angiotensin Converting Enzyme Inhibitor

Enalapril, Proteinuria < 1g/day; Enalapril, Proteinuria > 1g/day

Calcium Supplement DRUG

Calcium 2.5-20 mg/day

Also known as: Calcium lactate

Calcium, Proteinuria < 1g/day; Calcium, Proteinuria > 1g/day

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females between 18-70 years of age
• CKDu Grade 1, 2, 3
• No contraindication for treatment with ACEI
• Informed consent given

You may not qualify if:

• Grade 4 CKDu
• Other chronic diseases
• Evidence or suspicion of non renal secondary hypertension
• Diabetes type 1 or 2
• Evidence or suspicion of renovascular disease, obstructive uropathy, or other renal disease
• Treatment with corticosteroids, non-steroidal anti-inflammatory drugs, or immune-suppressive drugs
• Acute myocardial infarction or cerebrovascular accident in the previous 6 months
• Severe uncontrolled hypertension (diastolic blood pressure ≥115 and/or systolic blood pressure ≥220 mm Hg)
• Suspicion or evidence of connective tissue disease, cancer, higher serum aminotransferase concentrations
• Chronic cough; drug or alcohol abuse; pregnancy and breast feeding
• Unwillingness to sign informed consent

Sponsors & Collaborators

• Ministry of Health, Sri Lanka: lead
• World Health Organization: collaborator

Study Sites (1)

General (Teaching) Hospital, Anuradhapura

Anuradhapura, North Central Province, Sri Lanka

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Enalapril; Angiotensin-Converting Enzyme Inhibitors; calcium lactate

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)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Selvarajah Mathu, MBBS, MD

  Ministry of Health

  PRINCIPAL INVESTIGATOR

• Shanthi Mendis, MBBS, MD

  World Health Organization

  PRINCIPAL INVESTIGATOR

• Rezvi Sheriff, MBBS, MD

  University of Colombo

  PRINCIPAL INVESTIGATOR

• Thilak Abeysekera, MBBS, MD

  Ministry of Health

  PRINCIPAL INVESTIGATOR

• Saroj Jayasinghe, MBBS, MD

  University of Colombo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Selvarajah Mathu, MBBS, MD

CONTACT

94-77-7390628; mathuselvarajah@yahoo.com

Navaratnasingam Janakan, MBBS, MSc, MD

CONTACT

94-77-7489813; navajanakan@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2012
• First Posted: June 20, 2012
• Study Start: August 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2013
• Last Updated: June 20, 2012

Record last verified: 2012-06

Locations

SR (1)