Metformin in Moderate and Severe Renal Failure (CKD 3-4): A Follow-up Study

NCT02848508 | Withdrawn Phase 2

• 1 other identifier: PI2016_843_0009
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To validate on the mid-term in moderate and severe renal failure (CKD 3-4) a nomogram to adapt a fixed metformin daily posology according to renal function on the basis of the first short-term study made by the investigators.

Conditions

Renal Insufficiency, Chronic

Keywords

Metformin; moderate renal failure; severe renal failure; chronic kidney disease; hyperlactatemia; lactic acidosis

Outcome Measures

Primary Outcomes (2)

• Monitoring of blood metformin plasma levels with a fixed dose of metformin

  4 months

• Monitoring of blood metformin erythrocytes levels with a fixed dose of metformin

  4 months

Study Arms (3)

moderate impairment, CKD stage 3a

EXPERIMENTAL

(12 subjects): GFR 59-45 (moderate impairment, CKD stage 3a) Metformin : 1500mg/day

Drug: Metformin

moderate impairment, CKD stage 3a)

EXPERIMENTAL

(12subjects): GFR 44-30 (moderate impairment, CKD stage 3b) Metformin : 1000mg/day

Drug: Metformin

severe impairment

EXPERIMENTAL

(12 subjects): GFR 29-15 (severe impairment, CKD stage 4) Metformin : 500mg/day

Drug: Metformin

Interventions

Metformin DRUG

Also known as: Glucophage

moderate impairment, CKD stage 3a; moderate impairment, CKD stage 3a); severe impairment

Eligibility Criteria

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

You may qualify if:

• Type 2 diabetes patients with stable CKD stages 3A, 3B and 4 aged between 18 and 80 years requiring metformin (and any other antidiabetic treatment)

You may not qualify if:

• Hyperlactatemia (\> 2.5 mmol/L)
• No creatinine levels available since 3 months
• Severe hepatic insufficiency
• No liver function parameters available
• Need of investigation with iodized contrast media
• Hypersensitivity to metformin

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Insufficiency; Hyperlactatemia; Acidosis, Lactic

Interventions

Metformin

Condition Hierarchy (Ancestors)

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; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Acidosis; Acid-Base Imbalance

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Jean-Daniel LALAU, MD, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: July 28, 2016
• Study Start: March 16, 2016
• Primary Completion: June 7, 2017
• Study Completion: June 7, 2017
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

FR (1)